Disposable Gloves - Robinson · PDF file116 Disposable Gloves Nytraguard® is the...

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Transcript of Disposable Gloves - Robinson · PDF file116 Disposable Gloves Nytraguard® is the...

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Nytraguard® is the Readigloves® brand name for nitrileexamination gloves. Nitrile is rapidly becoming the material ofchoice for many healthcare workers as it has similar propertiesto latex, but benefits from being free of any natural rubberlatex proteins.

Nytraguard® gloves have the following features and benefits:

• High stretch & elasticity - for superior comfort

• Superior resistance to chemicals - particularly cleaning andpetroleum based solvents

• Strong & durable - excellent puncture resistance

• Fingertip textured - for added finger grip with smoother palms for patient comfort

• Excellent barrier protection - effective against all biological organisms

• Latex free - free from natural rubber latex proteins to prevent Type I (latex) allergies and sensitisation

• Super low dermatitis risk option - accelerator and sulphur free variant for a chemically pure glove

• Easy donning - inside of glove specially treated for ease of donning

• Powder free

Within the Nytraguard® range, there are four differentglove options, allowing you to select the glove most suitedto your requirements. They are listed below, lightest gaugefirst. The range allows the user to select the combinationof cost, strength, sensitivity and dermatologicalperformance that best suits the task.

• Nytraguard® Bluple® - super lightweight, thin wall technology for optimum sensitivity and comfort, whilst maintaining excellent durability and strength. This glove is designed for high volume general medical tasks, as it combines comfort and sensitivity with great durability. Used widely in hospitals, it is available packed in 200’s for minimum packaging cost and maximum user convenience - and in a distinctive colour - Bluple!!

• Nytraguard® SkyBlue - a lightweight, high performance glove - offering high tactility and dexterity in a slightly heavier and more durable gauge than Bluple®. A very good all round medical glove.

• Nytraguard® ChemoPure® - a very high specification lightweight glove which combines a superior degree of chemical resisitance (including aggressive chemotherapy drugs) with a super-pure material formulation - hence the name ChemoPure. Independently tested in the UK, ChemoPure is certified for complex risk PPE tasks in either a clinical or laboratory setting. It’s super pure formulation isfree, not only of chemical accelerators but also free of sulphur - a world first! This massively reduces the risk of triggering Type IV delayed hypersensitivity reactions (contact dermatitis). ChemoPure is probably the best glove on the market for reducing the risk of skin reactions. It combines this outstanding performance with high tactility and dexterity from its lightweight construction.

• Nytraguard® Tough - a heavier weight glove when extra strength, durability and protection is of prime concern. Can be used for a wide variety of tasks - both medical and general purpose.

Readigloves® is the new name in high quality, high performance single use medical examinationgloves. As a minimum, all products in the Readigloves® range are fully compliant with the MedicalDevices Directive 93/42/EEC and the Personal Protective Equipment Directive (PPE) 89/686/EECfor Minimal Risks. The Readigloves® range features some of the latest, advanced formula materialsand manufacturing technology to deliver barrier protection without breaking budget constraints.

Readigloves® - For Enhanced Protection

Nytraguard® Nitrile Gloves

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Cyraguard® is the Readigloves® brand name for latexexamination gloves. Latex is the traditional material used toproduce examination gloves, manufactured from natural rubberlatex (NRL) extracted from rubber trees. Latex gloves offer highperformance thanks to the highly elastic properties of NRL.

Cyraguard® gloves have the following features and benefits:

• Superior grip - naturally ‘grippy’ material is ideal for precision tasks

• Excellent stretch - conforms easily to the hand, offering the highest levels of user comfort

• Superior dexterity - thin wall construction for a close fit and excellent sensitivity and tactility

• High durability - excellent tear resistance, even when punctured

• Easy donning - inside of glove specially treated for ease of donning

• Barrier protection - excellent protection against all biological organisms

• Minimised free natural rubber latex proteins - advanced manufacturing minimises latex allergic reaction risk

• Highly biodegradeable - made from natural materials

• Powder free

Latex is the gold standard in glove material construction due toits performance, comfort, tactility and grip. It should be notedhowever that some individuals can develop a sensitisation tolatex proteins - and in some cases can experience a severereaction - a Type I (natural rubber latex) allergic reaction. In orderto significantly reduce this risk. Cyraguard® latex gloves undergoa special manufacturing process which minimises free latexprotein levels. However, if an individual has a latex allergy, werecommend using Nytraguard® nitrile gloves as an alternative.

Within the Cyraguard® range, there are two different gloveoptions, for either added durability or improved dexterity:

• Cyraguard® Premium - heavyweight latex for the ultimate in barrier protection, durability and strength - but still offering high degrees of comfort and dexterity and sensitivity.

• Cyraguard® Essentials - lightweight latex, offering increased levels of comfort, dexterity and sensitivity of touch.

Vinoguard® is the Readigloves® brand name for vinyl gloves.Vinyl is a synthetic polymer, more commonly known as polyvinylchloride (PVC). Vinyl gloves are a low cost option for minimal risk tasks, as they are of lower performance than nitrile and latex gloves.

Vinoguard® gloves have the following features and benefits:

• Smooth finish - silky finish either wet or dry, ideal for washing patients and fragile skin contact

• Regulatory compliance - medical grade and minimal risk PPE, for low-risk tasks

• Cost effective - low cost, suitable for general purpose and patient care tasks

• Low elasticity - looser fit, but strong enough to prevent rippingon donning

• Higher stretch options - stretch vinyl version available, forimproved fit, comfort and dexterity

• Latex free - to prevent Type I (natural rubber latex) allergies

• Barrier protection - basic protection against biological organisms

• Powder free

Many vinyl gloves available on the market today do notcomply with the Medical Devices Directive. All products in theReadigloves® Vinoguard® range comply fully with theDirective, and may, therefore be used for medicalexamination purposes, as well as general purpose tasks.

Within the Vinoguard® range there are three different gloveoptions, to cater for all budgets and user requirements:

• Vinoguard® Synthetic - a heavyweight synthetic stretch vinyl, in a characteristically cream colour, with additional stretch qualities for improved comfort and fit. This is the highest specification glove in the Vinoguard range.

• Vinoguard® Premium - heavyweight vinyl for improved durability and strength.

• Vinoguard® Essentials - lightweight vinyl, for the cost-conscious, but still fully certified to the Medical Devices Directive.

Cyraguard® Latex Gloves

Vinoguard® Vinyl Gloves

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Choosing the correct gloves to provide the protection and dexterity for a specific task is not alwaysstraightforward. We have therefore created the following table to summarise the differences between themain glove material types. We have produced a detailed comparison for every glove type at the end ofthis section of the catalogue.

Choosing the Right Glove

Readigloves® Range Performance Chart

Toughness & Durability

Grip

Sensitivity & Tactility

Comfort, Fit & Dexterity

Chemical Resistance

Barrier Performance

Tear Resistance

Food Contact

Rating: Fair Good Very Good Excellent

Approximate ratings are relative and for guidance only. See page 121 for detailed information.

Toughness & Durability It is essential that gloves retain their integrity and resist tearing both when donning and in use. Nitrile and latexgloves are naturally more durable in use and less likely to rip on donning than vinyl gloves – even though they canbe thinner than vinyl. This is due to the superior material characteristics. The Readigloves® range offers differentthickness options within each glove material type – the thicker the glove, the more durable – though sensitivity anddexterity reduce with increasing thickness.

Grip The requirement for grip varies with the task being performed. For example, when manipulating a surgicalinstrument, a firm and reliable grip is critical. When caring for the elderly and patient bathing, a high level of grip isundesirable as it can cause discomfort or damage to the skin. The level of grip offered by a glove is dependent onthe molecular structure of the material and whether the surface has a texture applied. Texture helps provide wetgrip. Cyraguard® Latex offers the maximum grip, as it is naturally ‘grippy’ material. Cyraguard® Premium has an all-over micro texture for maximum grip and Cyraguard® Essentials has a smooth finish but is still ‘grippy’.Nytraguard® Nitrile gloves are less grippy than latex and the fingertips only are textured. They provide anintermediate level of grip suitable for most tasks. Finally, vinyl is naturally smooth and silky, with no addedtexturing so it has the lowest grip of the material types - making Vinoguard® the gloves of choice for patientcomfort, particularly in the care of the elderly.

Sensitivity & Tactility Sensitivity of touch is needed if handling small objects, holding delicate items, feeling for veins when inserting acannula or taking blood, etc. Latex are the best gloves for sensitivity as they are very close fitting and very stretchy.Thin nitrile, such as the Nytraguard® Bluple® offer slightly less sensitivity than latex but are still very good. Vinylgloves, in comparison offer low sensitivity.

Properties Latex Nitrile Stretch Vinyl Vinyl Cyraguard® Nytraguard® Vinoguard® Vinoguard®

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s Choosing the Right Glove (continued)

Chemical Resistance The Readigloves® range of latex, nitrile and vinyl gloves are medical examination gloves and in general are notspecifically for use with aggressive chemicals. However, they are resistant to a wide range of chemicals – eachmaterial type having different resistance characteristics. Nitrile has a very broad spectrum of chemical resistance -latex less so as it can break down if certain oil based products come into contact with it. Details available onrequest. All of the Readigloves® range is certified for use as PPE but for minimal risk applications only.Nytraguard® ChemoPure® gloves have been extensively tested and are certified as complex PPE for handlingpotentially dangerous chemicals. They exhibit excellent chemical resistance, in particular, to aggressivechemotherapy drugs. Before using a glove with chemicals, a risk assessment should be undertaken and the glovechosen which provides protection from the chemical of interest. Generally, vinyl gloves offer the least chemicalresistance but are suitable for use with diluted detergent solutions for cleaning.

Barrier Performance Medical examination gloves protect both the wearer and the patient against cross infection risk. Latex and nitrilegloves have exceptionally high biological barrier characteristics. In addition, the more durable a glove, the lesslikely it is to tear – and a torn glove offers no barrier protection at all! Nitrile and latex gloves have excellentdurability. Vinyl gloves offer much lower barrier protection due to their material composition and lower durability –so they are suitable for lower risk clinical tasks only.

Tear Resistance Tearing occurs typically on donning and in use. On donning, gloves can tear at the cuff. Latex and nitrile glovesoffer excellent performance against cuff tearing as they are very stretchy. Vinyl gloves are more prone to tearing,particularly if they are a tight fit or pulled on too roughly – though Vinoguard® gloves are heavier gauge than normalto reduce this risk. Tearing can also occur in use – usually when the material is punctured or snagged. Latex andnitrile are both very resistant. In particular, Nitrile has a very high puncture resistance though once punctured tearsquickly. Vinyl is the most likely to tear in use. In addition to these material differences, the thicker the glove within amaterial type, the better the tear resistance. Note that long fingernails and rings can cause gloves to tear.

Latex Allergy Risk Certain individuals may be sensitive to the proteins found in natural rubber latex. This can cause effects rangingfrom mild skin irritation to a severe allergic reaction known as a Type I natural rubber latex allergic reaction. This iscaused when the latex proteins come into contact directly with the skin or mucous tissue, or alternatively when theproteins are carried in the air – usually attached to glove powder. Although it seems an obvious point, only latexgloves contain natural rubber latex proteins. Nitrile and vinyl are latex free. Cyraguard® Latex gloves are speciallytreated to minimise the free latex proteins, though use by sensitive individuals should be avoided. Productscontaining natural rubber latex are marked on the carton with the symbol displayed on the left.

Contact Dermatitis Risk Many people believe that if they choose nitrile or vinyl gloves they can avoid skin reactions – but that is not true.They can avoid a natural rubber latex allergic reaction as there is no latex in these gloves but they can suffer fromcontact dermatitis. This is caused by sensitivity to free chemicals in the gloves, typically sulphur and acceleratorsused in nitrile gloves – known as a Type IV Chemical Allergy. The chemistry used in Nytraguard® gloves is highlyadvanced with extremely low levels of sensitising chemicals – but the ultimate performing glove in this regard isChemoPure® – which is completely absent of sulphur and accelerator chemicals. Many healthcare workers sufferbadly with cracked hands due to repeated washing which makes them more sensitive to glove chemicals – soChemoPure® should be used by these individuals.

Comfort, Fit & DexterityThe more stretch a glove has, the better it will conform to your hand and the less effort it will take to move thehand and fingers – thus reducing hand fatigue and increasing both dexterity and comfort levels. Latex offers thehighest stretch, dexterity and comfort, closely followed by thin wall nitrile like Nytraguard® Bluple®. Vinyl gloveshave much lower levels of stretch – though the range includes a synthetic vinyl which offers more stretch andcomfort than standard vinyl. Latex gloves are quite tolerant when trying to don too small a glove – as they stretchto fit the hand. Nitrile, being a bit less stretchy, are slightly less tolerant, and vinyl gloves really need to be thecorrect size for the hand – and may require a larger size to prevent ripping on donning. Robinson Healthcareoperates a free glove sample service for the entire Readigloves® range - this is the best way to check your size,before ordering in bulk as these can vary by manufacturer.

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Characteristic Bluple® SkyBlue Tough ChemoPure® Premium Essentials Synthetic Premium Essentials

Toughness & Durability 8 9 10 9 9 7 5 4 3

Grip 7 7 8 7 10 9 3 3 3

Sensitivity & Tactility 9 8 7 8 9 10 4 2 3

Comfort, Fit & Dexterity 9 8 7 8 9 10 4 3 2

Chemical Resistance1 8 9 10 10 7 7 3 3 2

Barrier Performance 9 9 10 10 10 9 4 3 2

Tear Resistance2 9 9 10 9 10 7 4 3 2

Puncture Resistance 8 9 10 9 7 6 4 3 2

Latex Allergy Risk3 10 10 10 10 5 5 10 10 10

Contact Dermatitis Risk3 7 7 7 10 7 7 6 6 6

Ease of Donning 9 9 8 9 9 9 5 3 2

Powder Content Powder Free Powder Free Powder Free

Food Contact 9 9 9 10 8 8 4 4 4

Food Contact When handling food, it is very important that chemicals in the glove do not leach out and get onto the food wherethey could be ingested. The food itself can trigger the release of these chemicals – depending on the glove materialtype. Cyraguard® latex and Nytraguard® nitrile glove ranges are approved for contact with all types of food. Vinylgloves are frequently used for food preparation, but nearly all types are only suitable for safe use with non-fatty foods- and most foods are fatty.

Ease of Donning Gloves can be difficult to don, particularly if the hands are wet or the glove is too small. All latex and nitrile gloves arespecially treated inside to ease the donning process. Vinyl are not treated – though the fact that they are normallyworn baggy and that they are naturally slippery helps donning.

Powder Content None of the Robinson Readigloves® ranges in this catalogue are powdered. This is because they are speciallymanufactured so that powder is not needed to aid donning. In addition, powder can leave an unpleasant residue onthe hand after use (it combines with sweat) and it can cause natural rubber latex proteins to become airborne if theycombine with the powder.

Nitrile Latex Vinyl

Nytraguard® Cyraguard® Vinoguard®

Individual Glove Performance Chart

Approximate ratings are relative and for guidance only.

1 Depends on specific chemical

2 Once punctured, nitrile tears easily - but is highly resistant to puncturing

3 A high number indicates the best performing glove to reduce natural rubber latex allergy and contact dermatitis risk

Scale: 1 = Worse/Very Poor Performance, 10 = Best/Excellent Performance.

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Product Code Size Gloves per Carton Unit of Sale

9535 Extra Small 100 10 Cartons9536 Small 100 10 Cartons9537 Medium 100 10 Cartons9538 Large 100 10 Cartons9539 Extra Large 100 10 Cartons

9545 Extra Small 200 10 Cartons9546 Small 200 10 Cartons9547 Medium 200 10 Cartons9548 Large 200 10 Cartons9549 Extra Large 200 10 Cartons

EN 374-3EN 374-2

Level 2

AQL1.5

Technical Performance

Classification: Single use medical examination glove, Non sterile Class I Medical Device

Materials: Acrylonitrile butadiene; Does not contain latexDoes not contain styrene; Powder free

Design: Ambidextrous, finger textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Medical Devices Directive 93/42/EECCompliance: - BS EN 455, Parts 1, 2, 3 and 4. Medical gloves for

single use - Minimum force at break - 6 Newtons- EN ISO 10993, Biological evaluation of medical devices

Personal Protective Equipment Directive 89/686/EEC- Simple design- BS EN 420. Protective gloves - general requirements and test methods - Gloves are 240mm in length for medical applications - Dexterity level 5 (high dexterity)- BS EN 374 parts 1, 2 and 3. Protective gloves against chemicals and micro organisms - Micro organism resistant - Low level chemical protection

Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011. Plastic materials and articles intended to come into contact with food- BS EN 1186. Materials and articles in contact with foodstuffs - plastics- Suitable for all food types

Applications: Hospital - medium to high risk clinical procedures and routine tasks, community nursing, GP surgeries, dental surgeries, emergency services, nursing homes, care homes, domiciliary care, general use, cleaning, light industrial, local authority, police, customs, education, food and catering

Readigloves® Nytraguard® Bluple®

Advanced Formula Nitrile Gloves

Nytraguard® Bluple® is no ordinary glove; it provides the latest in thin wall nitrile technology without compromising on strength. An innovation in high performance nitrile gloves, this medical grade, super lightweight glove gives you high comfort, great sensitivityand toughness - an unbeatable combination and in a distinctive new colour - Bluple!

• Super lightweight, thin wall construction - very high sensitivity

• High stretch - very high degree of comfort and fit

• High durability - tear and puncture resistance

• Maximum biological resistance - for protection

• Medium grip - suitable for multiple tasks, fingertip textured

• Easy donning - for speed and convenience

• Powder free - for hygiene and convenience

• Latex free - no risk of natural rubber latex allergic reaction

• Food contact approved - safe for use with all food types

• Colour - blue/purple

Nytraguard® Bluple® is the optimum solution for high volume nitrile glove requirements in acute and community healthcaresettings, but equally at home for a variety of non clinical tasks. Because of its high sensitivity and dexterity this glove is idealfor dental procedures. Nytraguard® Bluple® gloves are available in cartons of 100 as standard, or in more economical 200glove cartons, for cost efficiency and reduced frequency of replacement.

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• Super pure material - ultra low dermatitis risk and zeronatural rubber latex allergy risk

• High chemotherapy drug resistance - class leadingprotection for safety in use. Tested to ASTM D6978-05

• High chemical resistance - protection against a widerange of hospital and laboratory chemicals

• High puncture resistance - certified to ASTM F1342

• Suitable for laboratory and PPE use - independentlycertified design and production

• Lightweight construction - for high sensitivity

• High stretch - for a high degree of comfort and fit

• Very high durability - for tear and puncture resistance

• Ultimate biological resistance - independently certified toASTM D1671 for ultimate resistance to viral penetration

• Medium grip - suitable for multiple tasks – fingertiptextured

• Easy donning - for speed and convenience

• Powder free - for hygiene and convenience

• Latex free - no risk of natural rubber latex allergy

• Food contact approved - safe for use with all food types

• Colour - dark purple

Readigloves® Nytraguard® ChemoPure®

Chemically Resistant & Pure Nitrile Gloves - Sulphur Free

Nytraguard® ChemoPure® is a completely unique glove. Its name is derived from the combination of chemical resistance and highmaterial purity, delivered in one groundbreaking glove. ChemoPure® is the first in a new generation of high specification, versatilemedical gloves that provide protection in both a clinical and laboratory environment. Free from latex, sulphur and acceleratorsChemoPure® is the pure solution that guards the user against the main causes of contact dermatitis and natural rubber latexallergies. This glove is probably the best medical glove on the market!

The Most Skin Friendly Glove on the MarketIt is well known that large numbers of clinical staff suffer from anadverse reaction to medical gloves. This is caused by compoundsin the glove which react with the skin. Because clinical staffrepeatedly wash their hands and/or apply alcohol gel, the naturaloils in the skin are removed leading to dry, cracked and sorehands. This makes them much more sensitive to irritantcompounds in the glove.

ChemoPure® Provides the Answer

• First, ChemoPure® is latex free, so there is no risk of a Type Inatural rubber latex allergic reaction

• Second, ChemoPure® is free of chemical accelerators. Skin isvery sensitive to chemical accelerators and these can lead toType IV contact dermatitis. The risk of dermatitis is as low as it ispossible to be with ChemoPure®

• Third, ChemoPure® uses a world first, unique formula which iscompletely sulphur free to further improve its skin friendlyperformance

So if your staff suffer from skin irritation - supply them withChemoPure®. Happier staff, reduced absence from damagedhands and no personal injury claims makes everyone happy - andfor a minimal increase in cost.

The table on the right shows the test results for all commonchemical accelerators. It can be seen that these accelerators arenot present or they are so low that they are undetectable.

Notes: Five grams of the sample was extracted in 100ml boiling deionizedwater for one hour. The water extract was then liquid-liquid extractedusing methylene chloride. The extracted chemicals were individuallydetermined via HPLC by comparing them to authentic reference material.The limits of detection are 2µg/ml for ZDEC and 10µg/ml for TMTD, MBT,ZDMC, ZPMC, ZDBC, ZMBI, ZMBT, BHT, BHA, DPG and DPT. Chemicaldetermined as non-detected is either not present or the concentration isbelow the detectable limit.

No Chemical Test Results

1 Butylated hydroxyanisole (BHA) Non detected2 Butylated hydroxytoluene (BHT) Non detected3 Diphenyl guanidine (DPG) Non detected4 Diphenyl thiourea (DPT) Non detected5 Mercaptobenzothiazole (MBT) Non detected6 Tetramethylthiuram disulphide (TMTD) Non detected7 Zinc dibutyldithiocarbamate (ZDBC) Non detected8 Zinc diethyldithiocarbamate (ZDEC) Non detected9 Zinc dimethyldithiocarbamate (ZDMC) Non detected10 Zinc mercaptobenzimidazole (ZMBI) Non detected11 Zinc mercaptobenzothiazole (ZMBT) Non detected12 Zinc pentamethylenedithiocarbamate (ZPMC) Non detected

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ASTM D6978-05 Test Results

The Best Glove for Chemotherapy DrugResistanceIt should be noted that drugs (and other chemicals) can permeate(go right through) an otherwise waterproof glove. This can lullclinicians into a false sense of security. In particular, most medicalgloves have a very low resistance to the accidental spillage ofcytotoxic chemotherapy drugs. This could pose a significant risk toclinical staff. ChemoPure® is different; its unique sulphur free,accelerator free formulation gives it remarkable resistance to themost aggressive chemotherapy drugs (including Carmustine andThioTEPA).

ChemoPure® is permeation tested to the most onerous globalstandard - ASTM D 6978-05. The outstanding results are shownbelow:

Chemical Protection Level

40% Sodium hydroxide 65% Ethidium bromide 637% Formaldehyde 60.1% Phenol 610-13% Sodium hypochlorite 650% Sulphuric acid 61.5% Methanol in water 650% Gluteraldehyde 670% Isopropanol 1

Test Chemotherapy Drug Average BreakthroughDetection Time (mins)

Carmustine (BCNU), 16.703.3mg/ml (3,300 ppm)

Cisplatin, No Breakthrough Up To 240 min1.0 mg/ml (1,000 ppm)

Cyclophosphamide, (Cytoxan) No Breakthrough Up To 240 min20.0 mg/ml (20,000 ppm)

Dacarbazine, (DTIC), No Breakthrough Up To 240 min10.0 mg/ml (10,000 ppm)

Doxorubicin Hydrochloride, No Breakthrough Up To 240 min2.0 mg/ml (2,000 ppm)

Etoposide, (Toposar) No Breakthrough Up To 240 min20.0 mg/ml (20,000 ppm)

5 - Fluorouracil, No Breakthrough Up To 240 min50.0 mg/ml (50,000 ppm)

Paclitaxel, (Taxol), No Breakthrough Up To 240 min6.0 mg/ml (6,000 ppm)

ThioTEPA, 72.3610.0 mg/ml (10,000 ppm)

Excellent chemical resistance – certified for usein laboratories and resistant to commonhospital chemicalsChemoPure® is independently certified for its protectiveperformance by a UK test laboratory. In addition, themanufacturing process is also independently supervised andcertified to ensure consistency of product quality.

These two key factors are required by law to claim compliancewith the Personal Protective Equipment Directive 89/686/EEC,Complex design PPE for high risk use.

The table below shows the resistance of ChemoPure® tochemical permeation, tested to EN 374-1 using the protocol inEN 374-3 (excluding clause 5.3.2). Note that level 6 is themaximum achievable under the test protocol (protection forlonger than 480 minutes) and 1 is the least (protection for longerthan 10 minutes). It can be seen that the performance isexcellent.

Warning: Please note breakthrough time. In the event of accidentalspillage of Carmustine and ThioTEPA we recommend glove removalwithin 15 minutes.

Readigloves® Nytraguard® ChemoPure®

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EN 374-3EN 374-2

Level 2

AQL1.5

ASTMD6978-05

ASTMF1671

ASTMF1342

Product Code Size Gloves per Carton Unit of Sale

9540 Extra Small 100 10 Cartons9541 Small 100 10 Cartons9542 Medium 100 10 Cartons9543 Large 100 10 Cartons9544 Extra Large 100 10 Cartons

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Readigloves® Nytraguard® ChemoPure®

Technical Performance

Classification: Single use medical examination and laboratory glove, Non sterile Class l Medical Device

Materials: Acrylonitrile butadiene; Accelerator and sulphur free;Does not contain latex; Does not contain styrene; Powder free

Design: Ambidextrous, finger textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Compliance: Medical Devices Directive 93/42/EEC

- BS EN 455, Parts 1, 2, 3 and 4. Medical gloves for single use - Minimum force at break - 6 Newtons- EN ISO 10993, Biological evaluation of medical devices

Personal Protective Equipment Directive 89/686/EEC- Complex design for high risk use- BS EN 420. Protective gloves – general requirements and test methods - Gloves are 240mm in length for medical applications - Dexterity level 5 (high dexterity)- BS EN 374 parts 1, 2 and 3. Protective gloves against chemicals and micro organisms - Micro organism resistant - High level of chemical protection against specified chemicals

Specialised test compliance- ASTM D 6978-05. Resistance of medical gloves to permeation by chemotherapy drugs

- ASTM F 1671-07. Resistance of materials used in protective clothing to penetration by blood-borne pathogens

- ASTM F 1342. Standard test method for protective clothing – material resistance to puncture

Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011. Plastic materials and articles intended to come into contact with food- BS EN 1186 materials and articles in contact with foodstuffs - plastics- Suitable for all food types

Applications: Specialist applicationsHospital clinical procedures, including administration of chemotherapy drugs or handling chemicals, contact with high risk patients (viral infection risk), laboratory use (see chemical resistance chart)General applications where low dermatitis glove is requiredCommunity nursing, GP surgeries, dental surgeries, emergency services, nursing homes, care homes, domiciliary care, general use, cleaning, light industrial, local authority, police, customs, education, food and catering

Outstanding Viral Penetration ResistanceIn the same way that many people don’t realise that chemicalscan literally permeate right through a glove into the body (eventhough the glove is intact), a similar situation can occur withmicrobiological organisms.

Readigloves® nitrile and latex gloves offer exeptionally goodmicrobiological resistance, but vinyl gloves offer a much lowerresistance. The tests required in BS EN 455 and BS EN 374 aregeneral in nature and require only water and air tightness. Theydo not specifically test the performance of the gloves againstbacteria, fungi and viruses.

Viruses (smaller than bacteria and fungi) could have devastatingconsequences if they come into contact with a healthcareworker – particularly hepatitis B and C and the HIV virus.

We have therefore had ChemoPure® tested to ASTM D 1671:resistance of materials used in protective clothing topenetration by blood-borne pathogens using Phi-X174bacteriophage penetration as a test system (viral penetration).

The unique formulation of ChemoPure® ensured it passed thisonerous test with flying colours.

ChemoPure® therefore has outstanding viral resistance andbecause bacteria and fungi are larger than viruses, outstandingresistance against these organisms too.

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The Nitrile Glove ‘All-Rounder’

Nytraguard® SkyBlue is a lightweight, high performance nitrile glove that is the perfect ‘all-round’ glove. Ideal for bothclinical and general tasks, it offers high comfort, stretch and dexterity without compromising on strength and durability.

• Lightweight construction - for high sensitivity

• High stretch - for a high degree of comfort and fit

• Very high durability - for tear and puncture resistance

• Maximum biological resistance - for protection

• Medium grip - suitable for multiple tasks, fingertip textured

• Easy donning - for speed and convenience

• Powder free - for hygiene and convenience

• Latex free - no risk of latex allergic reaction

• Food contact approved - safe for use with all food types

• Colour - mid blue

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Product Code Size Gloves per Carton Unit of Sale9526 Small 100 10 Cartons9527 Medium 100 10 Cartons9528 Large 100 10 Cartons

The key benefit of Nytraguard® SkyBlue is its suitability for so many tasks. It is a thicker, heavier grade nitrile thanNytraguard® Bluple®, the same thickness as Nytraguard® ChemoPure® and is lighter than Nytraguard® Tough. So if youneed more durability and protection than the super lightweight Nytraguard® Bluple®, then try SkyBlue. If you find thatNytraguard® Tough is too robust for your tasks, SkyBlue could fit the bill perfectly.

EN 374-3EN 374-2

Level 2

AQL1.5

Readigloves® Nytraguard® SkyBlue®

Technical Performance

Classification: Single use medical examination glove, Non sterile Class I Medical Device

Materials: Acrylonitrile butadiene; Does not contain natural rubber latex. Does not contain styrene; Powder free

Design: Ambidextrous, finger textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Medical Devices Directive 93/42/EECCompliance: - BS EN 455, Parts 1, 2, 3 and 4. Medical gloves for

single use - Minimum force at break - 6 Newtons- EN ISO 10993, Biological evaluation of medical devices

Personal Protective Equipment Directive 89/686/EEC- Simple design- BS EN 420. Protective gloves - general requirements and test methods - Gloves are 240mm in length for medical applications - Dexterity level 5 (high dexterity)- BS EN 374 parts 1, 2 and 3. Protective gloves against chemicals and micro organisms - Micro organism resistant - Low level chemical protection

Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011. Plastic materials and articles intended to come into contact with food- BS EN 1186. Materials and articles in contact with foodstuffs - plastics- Suitable for all food types

Applications: Hospital - medium to high risk clinical procedures and routine tasks, community nursing, GP surgeries, dental surgeries, emergency services, nursing homes, care homes, domiciliary care, general use, cleaning, light industrial, authority, police, customs, education, food and catering

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Strong & Durable Nitrile Gloves

Tough by name, tough by nature – Nytraguard® Tough is a heavy gauge nitrile glove for additional protection and optimumdurability. Designed for tasks where increased security takes priority over sensitivity of touch and tactility, Tough is dependable,every time. Comfortable, strong and durable – Tough works as hard as you do.

• Heavyweight construction - medium sensitivity

• Medium stretch - for a good degree of comfort and fit

• Extremely high durability - for tear and puncture resistance

• Maximum biological resistance - for protection

• High grip - suitable for tough tasks, fully textured

• Easy donning - for speed and convenience

• Powder free - for hygiene and convenience

• Latex free - no risk of latex allergic reaction

• Food contact approved - safe for use with all food types

• Colour - mid blue

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Product Code Size Gloves per Carton Unit of Sale9531 Small 100 10 Cartons9532 Medium 100 10 Cartons9533 Large 100 10 Cartons9534 Extra Large 100 10 Cartons

Nytraguard® Tough is the heaviest duty product of our nitrile glove range, though much thinner than household rubbergloves for example - and therefore still has relatively high dexterity levels. Nytraguard® Tough is suitable for use in higherrisk medical applications where the highest level of biological protection and durability is recommended. It is also very wellsuited to a wide range of cleaning, general industrial or motor industry tasks where the thinner grades of nitrile gloves arenot durable enough.

EN 374-3EN 374-2

Level 2

AQL1.5

Readigloves® Nytraguard® Tough

Technical Performance

Classification: Single use medical examination glove, Non sterile Class I Medical Device

Materials: Acrylonitrile butadiene; Does not contain natural rubber latex. Does not contain styrene; Powder free

Design: Ambidextrous, finger textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Medical Devices Directive 93/42/EECCompliance: - BS EN 455, Parts 1, 2, 3 and 4. Medical gloves for

single use - Minimum force at break - 6 Newtons- EN ISO 10993, Biological evaluation of medical devices

Personal Protective Equipment Directive 89/686/EEC- Simple design- BS EN 420. Protective gloves – general requirements and test methods - Gloves are 240mm in length for medical applications - Dexterity level 5- BS EN 374 parts 1, 2 and 3. Protective gloves against chemicals and micro organisms - Micro organism resistant - Low level chemical protection

Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011. Plastic materials and articles intended to come into contact with food- BS EN 1186. Materials and articles in contact with foodstuffs - plastics- Suitable for all food types

Applications: High risk medical applications, emergency services, cleaning - clinical and general, local authority, police, customs, light industrial use, motor industry, food and catering

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Readigloves® Cyraguard® PremiumHeavy Gauge Latex Gloves

Cyraguard® Premium gloves deliver outstanding performance in the critical areas of barrier protection, grip, comfort,sensitivity of touch, tactility and feel. The gold standard for medical examinations, they are manufactured from heavy gaugelatex and stringently tested to ensure the highest level of quality, every time.

• Heavyweight construction - high grade latex provides maximum sensitivity

• Ultimate stretch - for the ultimate in comfort and fit

• Very high durability - for tear and puncture resistance

• Ultimate biological resistance - for the best protection

• Ultimate grip - micro textured and grips even when wet

• Easy donning - for speed and convenience

• Advanced manufacturing - minimises free natural rubber latex proteins

• Powder free - for hygiene, convenience and reduced natural rubber latex allergy risk

• Contains natural rubber latex

• Food contact approved - safe for use with all food types

• Colour - cream

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EN 374-3EN 374-2

Level 2

Product Code Size Gloves per Carton Unit of Sale

9505 Extra Small 100 10 Cartons9506 Small 100 10 Cartons9507 Medium 100 10 Cartons9508 Large 100 10 Cartons9509 Extra Large 100 10 Cartons

Cyraguard® Premium is a very high quality latex glove, offering the highest comfort, highest sensitivity, highest dexterityand highest grip of all the Readigloves® range. In addition, its microbiological barrier performance is extremely high,though its chemical resistance is generally low. The advanced production process reduces free natural rubber latexproteins to an absolute minimum, though if you have a known latex allergy, we recommend you choose a nitrile glovefrom the Nytraguard® range.

Technical Performance

Classification: Single use medical examination glove, Non sterile Class I Medical Device

Materials: Natural rubber latex – special treatment minimises free latex proteins. Does not contain styrene; Powder free

Design: Ambidextrous, micro textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Latex Protein Contains natural rubber latexContent:

Shelf Life: 3 years

Regulatory Medical Devices Directive 93/42/EECCompliance: - BS EN 455, Parts 1, 2, 3 and 4. Medical gloves for

single use - Minimum force at break - 6 Newtons- EN ISO 10993, Biological evaluation of medical devices

Personal Protective Equipment Directive 89/686/EEC- Simple design- BS EN 420. Protective gloves – general requirements and test methods - Gloves are 240mm in length for medical applications - Dexterity level 5 (high dexterity)- BS EN 374 parts 1, 2 and 3. Protective gloves against chemicals and micro organisms - Micro organism resistant - Low level chemical protection

Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011. Plastic materials and articles intended to come into contact with food- BS EN 1186. Materials and articles in contact with foodstuffs - plastics- Suitable for all food types

Applications: Hospital - medium to high risk clinical procedures and routine tasks, community nursing, GP surgeries, dental surgeries, general use, cleaning, light duty industrial, local authority, police, customs, education, food and catering

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Cyraguard® Essentials is a high quality latex glove offering the highest comfort, highest sensitivity and highest dexterityof all the Readigloves® range. It offers very good microbiological barrier performance though limited chemical resistance.The advanced production process reduces free latex proteins to an absolute minimum, though if you have a knownnatural rubber latex allergy we recommend you choose a nitrile glove from the Nytraguard® range. The Cyraguard®Essentials glove is a lighter duty and a thinner gauge than Cyraguard® Premium, but is offered at a lower cost.

Readigloves® Cyraguard® Essentials

AQL1.5

EN 374-3EN 374-2

Level 2

High Dexterity Latex Gloves

Cyraguard® Essentials is a regular gauge latex glove, for increased sensitivity of touch and comfort. Stringently tested andapproved for medical examinations, this versatile glove offers a lower cost latex glove for a wide range of clinical and generalpurpose tasks.

• Regular construction - provides the ultimate in sensitivity

• Ultimate stretch - for the ultimate in comfort and fit

• Medium durability - for tear and puncture resistance

• Maximum biological resistance - for best protection

• High grip - naturally grippy material

• Easy donning - for speed and convenience

• Advanced manufacturing - minimises free natural rubber latex proteins

• Powder free - for hygiene, convenience and for reduced natural rubber latex allergy risk

• Contains natural rubber latex

• Food contact approved - safe for use with all food types

• Colour - cream

Product Code Size Gloves per Carton Unit of Sale9501 Small 100 10 Cartons9502 Medium 100 10 Cartons9503 Large 100 10 Cartons

Technical Performance

Classification: Single use medical examination glove, Non sterile Class I Medical Device

Materials: Natural rubber latex – special treatment minimises free latex proteins. Does not contain styrene; Powder free

Design: Ambidextrous, smooth outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Latex Protein Contains natural rubber latexContent:

Shelf Life: 3 years

Regulatory Medical Devices Directive 93/42/EECCompliance: - BS EN 455, Parts 1, 2, 3 and 4. Medical gloves for

single use - Minimum force at break - 6 Newtons- EN ISO 10993, Biological evaluation of medical devices

Personal Protective Equipment Directive 89/686/EEC- Simple design- BS EN 420. Protective gloves - general requirements and test methods - Gloves are 240mm in length for medical applications - Dexterity level 5 (high dexterity)- BS EN 374 parts 1, 2 and 3. Protective gloves against chemicals and micro organisms - Micro organism resistant - Low level chemical protection

Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011. Plastic materials and articles intended to come into contact with food- BS EN 1186. Materials and articles in contact with foodstuffs - plastics- Suitable for all food types

Applications: Hospital - low to medium risk clinical procedures and routine tasks, community nursing, GP surgeries, dental surgeries, General use, cleaning, light duty industrial, localauthority, police, customs, education, food and catering

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Stretch Vinyl Gloves

Vinoguard® Synthetic is no normal vinyl glove. The advanced formulation significantly improves the stretch and strength propertiescompared to normal vinyl gloves (though not at the same level of nitrile and latex gloves). It is slightly more expensive than standardvinyl but at a lower cost than latex and nitrile. This superior vinyl glove is characterised by its creamy appearance, and is oftenreferred to as pigmentised vinyl.

• Cost effective - lower cost than nitrile or latex

• Heavyweight construction - average level of sensitivity

• Medium stretch - good comfort and fit

• Good durability - suitable for a wide range of tasks

• Limited biological resistance - provides basic protection

• Low grip - ideal for handling frail skin and hair, not textured

• Powder free - for hygiene and convenience

• Food contact - approved for non fatty foods only

• Latex free - no risk of natural rubber latex allergy

• Colour - cream/ivory for improved appearance over standard vinyl

AQL1.5

Technical Performance

Classification: Single use medical examination glove, Non sterile Class I Medical Device

Materials: Pigmentised, synthetic, stretch Polyvinyl chloride; Does not contain latexDoes not contain styrene; Powder free

Design: Ambidextrous, micro textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Medical Devices Directive 93/42/EECCompliance: - BS EN 455, Parts 1, 2, 3 and 4. Medical gloves for

single use - Minimum force at break - 3.6 Newtons- EN ISO 10993, Biological evaluation of medical devices

Personal Protective Equipment Directive 89/686/EEC- Simple design- BS EN 420. Protective gloves - general requirements and test methods - Gloves are 240mm in length for medical applications - Dexterity level 5 - BS EN 374 parts 1, 2 and 3. Protective gloves against chemicals and micro organisms - Micro organism resistant - Low level chemical protection

Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011. Plastic materials and articles intended to come into contact with food- BS EN 1186. Materials and articles in contact with foodstuffs - plastics- Suitable for non-fatty foods only

Applications: Low risk clinical procedures and routine tasks, community nursing, GP surgeries, nursing homes, care homes, domiciliary care, general use, cleaning, light industrial, local authority, education

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Product Code Size Gloves per Carton Unit of Sale

9590 Extra Small 100 10 Cartons9591 Small 100 10 Cartons9592 Medium 100 10 Cartons9593 Large 100 10 Cartons9594 Extra Large 100 10 Cartons

Readigloves® Vinoguard® Synthetic

Vinoguard® Synthetic is best described as a glove which has a performance mid-way between the lower performing vinyl and thehigher performing nitrile and latex. The cost of the glove similarly, is between vinyl and nitrile/latex. It is ideal for low risk clinicaland general tasks where low grip is desirable (handling frail skin and hair) and where a relatively affordable and comfortable lowcost glove is required.

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Product Code Size Gloves per Carton Unit of Sale

9585 Extra Small 100 10 Cartons9586 Small 100 10 Cartons9587 Medium 100 10 Cartons9588 Large 100 10 Cartons9589 Extra Large 100 10 Cartons

AQL1.5

Heavier Gauge Vinyl Gloves

All vinyl gloves are not the same. Vinoguard® Premium is a high quality, durable alternative to the large number of low cost, cheap vinylgloves available today. Manufactured from a heavier, premium gauge PVC, Vinoguard® Premium gloves are stronger, so last longer,delivering real value for money for the cost conscious.

• Cost effective - lower cost than latex, nitrile or synthetic gloves

• Heavyweight construction - basic level of sensitivity

• Low stretch - Basic comfort and fit

• Good durability - suitable for a wide range of tasks

• Limited biological resistance - provides basic protection

• Low grip - ideal for handling frail skin and hair, not textured

• Power free - for hygiene and convenience

• Food contact - approved for non fatty foods only

• Latex free - no risk of natural rubber latex allergy

• Colour - translucent

Readigloves® Vinoguard® Premium

Vinyl gloves offer a lower level of performance than latex nitrile or synthetic gloves but at a lower cost. They are ideal for low riskapplications which do not require high degrees of durability, sensitivity, comfort or protection. Many vinyl gloves are so weak theybreak on donning or fail quickly in use. Vinoguard® is a premium grade glove which overcomes these common problems, but stillat a competitive price. They are ideal for low risk tasks, particularly in the care of the elderly.

Technical Performance

Classification: Single use medical examination glove, Non sterile Class I Medical Device

Materials: Polyvinyl chloride; Does not contain latexDoes not contain styrene; Powder free

Design: Ambidextrous, micro textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Medical Devices Directive 93/42/EECCompliance: - BS EN 455, Parts 1, 2, 3 and 4. Medical gloves for

single use - Minimum force at break - 3.6 Newtons- EN ISO 10993, Biological evaluation of medical devices

Personal Protective Equipment Directive 89/686/EEC- Simple design- BS EN 420. Protective gloves - general requirements and test methods - Gloves are 240mm in length for medical applications - Dexterity level 5 - BS EN 374 parts 1, 2 and 3. Protective gloves against chemicals and micro organisms - Micro organism resistant - Low level chemical protection

Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011. Plastic materials and articles intended to come into contact with food- BS EN 1186. Materials and articles in contact with foodstuffs - plastics- Suitable for non-fatty foods only

Applications: Low risk clinical procedures and routine tasks, community nursing, GP surgeries, nursing homes, care homes, domiciliary care, general use, cleaning, light industrial, local authority, education

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AQL1.5

132

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Readigloves® Vinoguard® Essentials

Vinoguard® Essentials is the glove to use if lowest cost is the main requirement. It is still fully compliant as an examinationglove but has limited applications. It is particularly suited to low risk tasks such as basic patient hygiene, care of the elderlyand cleaning.

Everyday Vinyl Gloves

When cost is the prime concern, Vinoguard® Essentials offer a quality vinyl glove that complies fully with the Medical DevicesDirective. Manufactured from regular gauge vinyl, Essentials is competitively priced and delivers value for money in use.

• Cost effective - the lowest cost glove

• Lightweight construction - basic sensitivity

• Low stretch - basic comfort and fit

• Basic durability - robust enough for basic tasks

• Limited biological resistance - provides basic protection

• Low grip - ideal for handling frail skin or hair, no texturing

• Powder free - for hygiene and convenience

• Food contact - approved for non fatty foods only

• Latex free - no risk of natural rubber latex allergy

• Colour - translucent

Product Code Size Gloves per Carton Unit of Sale

9581 Small 100 10 Cartons9582 Medium 100 10 Cartons9583 Large 100 10 Cartons

Technical Performance

Classification: Single use medical examination glove, Non sterile Class I Medical Device

Materials: Polyvinyl chloride; Does not contain latexDoes not contain styrene; Powder free

Design: Ambidextrous, micro textured outer surface, beaded cuff

Inspection Criteria: AQL 1.5

Shelf Life: 3 years

Regulatory Medical Devices Directive 93/42/EECCompliance: - BS EN 455, Parts 1, 2, 3 and 4. Medical gloves for

single use - Minimum force at break - 3.6 Newtons- EN ISO 10993, Biological evaluation of medical devices

Personal Protective Equipment Directive 89/686/EEC- Simple design- BS EN 420. Protective gloves – general requirements and test methods - Gloves are 240mm in length for medical applications - Dexterity level 5- BS EN 374 parts 1, 2 and 3. Protective gloves against chemicals and micro organisms - Micro organism resistant - Low level chemical protection

Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011. Plastic materials and articles intended to come into contact with food- BS EN 1186. Materials and articles in contact with foodstuffs - plastics- Suitable for non-fatty foods only

Applications: Low risk clinical procedures and routine tasks, community nursing, GP surgeries, nursing homes, care homes, domiciliary care, general use, cleaning, light industrial, local authority, education

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133

Legislation & Stand

ardsLegislation & Standards

Compliance with appropriate legislation and standards is fundamental to Robinson Healthcare’sphilosophy in all areas of the business, including the Readigloves® range. The result is high qualityproducts that not only exceed the necessary product and manufacturing standards, but also meetthe rigorous demands of our customers. Readigloves® are covered by two main regulations and anumber of product standards, which are detailed below.

This legislation covers all products in the Readigloves® rangeand is the principal legislation with the exception ofNytraguard® ChemoPure®, which is primarily covered by thePPE Directive. Medical devices are classified according to theinherent degree of risk to the patient or user, associated withtheir use and how invasive the device is during use.

Readigloves® are categorised as Class l Medical Devices asthey are non-invasive and are considered a comparatively lowrisk. However, the directive places legal obligations on themanufacturer to ensure that the devices are safe and fit fortheir intended purpose, such as gloves providing a suitablebiological barrier and retaining their integrity during use.

Every device must meet a number of “Essential Requirements”as stated in Annex l of the Directive. Demonstration that thedevice complies with these requirements forms part of thetechnical documentation required for all classes of device.These requirements include:

• Safety of patients and users

• Eliminating or addressing any risks associated with useof the product

• Performance of the device, initially and over life

• Biocompatibility, toxicity and flammability

• Elimination or reduction of any infection risk

• Appropriate environmentally controlled manufacturing conditions

• Correct unambiguous labelling

• Conformance with appropriate product standards

The manufacturer should also operate an appropriatequality management system - for medical devices this isISO 13485:2003 - and be registered with the CompetentAuthority responsible for regulatory compliance. In the UK thisis the Medicines and Healthcare products Regulatory Agency(MHRA). After issuing a declaration of conformity and applyinga CE mark, the product may be placed on the market. Themanufacturer must then maintain Post Market Surveillanceand take corrective action where required. More detailedinformation about the Medical Devices Directive and regulatorycompliance can be found at www.robinsonhealthcare.com.

The term ‘PPE’ covers any item designed to be worn or heldby an individual for protection against one or more health andsafety hazards. This is the principal legislation for gloves thatare used in a laboratory or in a clinical setting for morehazardous tasks such as for the administration ofchemotherapy drugs. It is therefore the most pertinentregulation for Nytraguard® ChemoPure®.

However, all gloves fall under the legislation as they may beused to handle cleaning chemicals.

The Directive provides a list of ‘simple’ and ‘complex’ designPPE and the manufacturer must decide to which category anitem belongs. This is defined as follows:

• Simple Design – Protects against minimal risks. The user can assess the level of protection required. The effects of the risk are gradual and can be safely identified by the userin good time.

• Complex Design – Protects against mortal danger, or against danger that may seriously and irreversibly harm health. The user cannot identify the immediate effects in sufficient time.

• Intermediate Design – Protection against risks that are not included in the exhaustive lists of simple or complexdesign PPE.

The manufacturer must compile a technical file that details

the following:

• Full design specification of the PPE

• List of basic health and safety requirements relating tothe PPE

• Details of the European standards to which the productis manufactured

• Details of other national standards to which the productis manufactured

• Performance characteristics of the PPE

If the PPE is of simple design, the manufacturer can make aself declaration of conformity to the Directive and place theproduct on the market, applying the CE mark. For complexdesign PPE, the manufacturer must submit the item for ECType Examination by an approved, independent Notified Body.The manufacturing must also be subject to one of two qualitycontrol systems, also audited by the Notified Body. Anappropriate quality management system, such as ISO 9001should be employed. If approved, the Notified Body will issue acertificate of conformance and the manufacturer may apply theCE mark with the Body’s identification number and then marketthe product.

Nytraguard® ChemoPure® has been independently certified toArticle 11B of the PPE Directive 89/686/EEC, as a Category lllcomplex design device and has been tested for high resistanceto a number of specific chemicals. All other products in theReadigloves® range conform to the Directive as Category lsimple design devices for minimal risks.

It is a legal requirement for all tasks that a risk assessmentshould be undertaken before selecting which glove should beused. This should form part of your organisation’s health andsafety policies. Gloves classified for minimal risks should NOTbe used for laboratory tasks.

Medical Device Classification

Class I Low risk (eg. Bandages; Gloves)Class IIa Medium risk (eg. Single use instruments)Class IIb Medium risk, complex design (eg. Wound contact layers)Class III High risk (eg. Pacemakers)

PPE Classification

Category Risk Example of Protection Simple Design Minimal Cleaning materials of weak actionPPE (Category l)

Intermediate Design Intermediate Not covered by simple or complex listPPE (Category ll)

Complex Design Serious Chemical attack (limited protection)PPE (Category lll)

Personal Protective Equipment (PPE) Directive 89/686/EEC

Medical Devices Directive 93/42/EEC, as amended by 2007/47/EC

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EN 455: Medical Gloves for Single UseThis standard is divided into four parts to cover specificrequirements:

EN 455-1: Requirements and Testing for Freedomfrom Holes

This standard covers the requirements and testing of glovesfor freedom from holes, with regard to penetration resistance.The standard uses a water leak test that is carried out usingAQL (Acceptable Quality Level) statistical sampling techniquesbased on production batch sizes. Gloves are tested by fillingwith water and observing for leaks. To comply, an AQL of 1.5or better is required (only 1.5% or less of the batch size mayhave a hole present).

EN 455-2: Requirements and Testing for Physical Properties

This standard covers physical properties such as dimensionsand force at break (minimum tensile strength) to ensure that thegloves meet minimum strength requirements to maintain theirintegrity in use. Minimum requirements are shown below.

Please note that the standard allows a lower strength of glovefor PVC (vinyl) of 3.6N. A fully compliant PVC (vinyl) glove isalmost always significantly weaker than a compliant latex ornitrile glove.

EN 455-3: Requirements and Testing for BiologicalEvaluation

This standard includes test procedures for measuring powderresidue for powder free gloves and leachable proteins in naturalrubber latex gloves, to determine levels of potential allergensand to disclose information to users. Gloves that contain ≤ 2 mg/dm2 of powder may be considered powder free. It is notpermissible to label latex gloves as low protein.

EN 455-4: Requirements and Testing for Shelf LifeDetermination

This standard covers the protocol to be followed to evaluate thegloves shelf life by using real time studies or a suitably validatedalternative for accelerated ageing. This also provides the userwith storage conditions to help maintain the integrity of theglove for the stated shelf life.

EN 374: Protective Gloves Against Chemicalsand Micro-organismsThis standard covers the requirements for gloves to protect theuser against chemicals and/or micro organisms. This standardis divided into 3 parts:

EN 374-1: Terminology and Performance Requirements

This section covers the performance requirements, markingof gloves and information to be supplied by the manufacturer.It does not specify requirements for protection against anymechanical hazards.

EN 374-2: Determination of Resistance to Penetration

This section describes the method of testing to determineresistance to penetration by micro organisms by way of a waterleak test and, if practicable, an air leak test. To comply with thestandard, the glove must achieve an AQL of 1.5 (see alsoEN455-1).

EN 374-3: Determination of Resistance to Permeationby Chemicals

Chemicals can penetrate through gloves even though the glovemay be intact and waterproof. This standard tests permeationperformance, and to claim general compliance (as per EN 374-1), the glove has to exhibit resistance to at least 3 of 12 testchemicals. The current standard allows a claim of low chemicalresistance if the glove passes water and air tightness.

The EN 374 standard is currently under review and is likely toallow testing of specific chemicals of interest.

ASTM D6978-05: Resistance of Medical Glovesto Permeation by Chemotherapy DrugsThis standard, issued by ASTM International (American Societyfor Testing and Materials) specifically covers resistance topermeation by chemotherapy drugs and is more rigorous thanthe European standard EN 374-3 as it classifies breakthroughat a much lower permeation level. The standard measures theresistance by actual breakthrough detection time of amandatory list of seven drugs, plus two more of themanufacturer’s choice.

ASTM F1671: Resistance of Protective Clothingto Penetration by Blood-Borne PathogensThis standard is more rigorous than EN 455-1 and EN 374-2(which use water and air leak tests) as it measures resistance topenetration by blood borne pathogens, specifically Hepatitis Band C and the HIV virus, using a surrogate microbe.

ASTM F1342: Test Method for ProtectiveClothing Material Resistance to PunctureThis standard specifically measures a material’s resistance topuncturing, using a probe of specific dimensions. This is usedto simulate as closely as possible the action of pointed objectscoming into contact with the glove.

EN 420: Protective Gloves: GeneralRequirements and Test MethodsThis standard covers the requirements for protective gloves andincludes: glove design; sizing; construction; innocuousness;comfort and efficiency; marking and information to be supplied.

Food CompatibilityThis is governed by Regulation (EC) No 1935/2004 and (EU)10/2011, plastic materials and articles intended to come intocontact with food. The text standard is BS EN 1186. Gloves aretested by exposing them to three substances to see ifcomponents in the glove are released which could potentiallycontaminate food.

• 10% Ethanol (alcohol, food and beverages)

• 3% Acetic Acid (acidic foods)

• Vegetable Oil (fatty foods)

Nitrile and latex Readigloves® are fully compatible with all foodtypes. Vinyl and Synthetic vinyl gloves are suitable for use withnon-fatty foods only. Please note that the majority of foods aredesignated ‘fatty’. Details available on request.

Dimensions of examination gloves

Size Median length (mm) Median width* (mm)

Extra Small > 240 < 80

Small > 240 80 + 10

Medium > 240 95 + 10

Large > 240 110 + 10

Extra Large > 240 > 110

Force at break of examination gloves

Type Before ageing (Newons) After ageing (Newtons)

Nitrile > 6 > 6Natural Rubber Latex > 6 > 6PVC (Vinyl) > 3.6 > 3.6

* width across palm

Legislation & Standards (continued)

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This sizing chart is provided for guidance only. Actual fit varies - depending on the material andthickness (weight and hand shape). To determine the most suitable size for any particular rangeof gloves, we recommend that you trial samples of 2 or more sizes.

Glove Size Guide

0 1

CM

2 3 4 5 6 7 8

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Place right handpalm down withfirst finger againstthe dotted line

Read off requiredsize here

To request samples -

Tel: 01909 735010 or

Email: [email protected]

Robinson Healthcare offers a fast and efficient samples service.

Glove Sample Service

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