Hygiene and ease-of-use

NON STERILEVINYL GLOVES

= Extra-LargeXL9 / 1 0

= LargeL8 / 9

= MediumM7 / 8

= SmallS6 / 7

= Extra-SmallXS5 / 6

Colour codesfor the differentglove sizes

General presentation

Exasyntil®Exanyl®

powder-free powder-free powder-freeExanyl Long®

Product codesXS: 447103XPS: 447103M: 447104L: 447105XL: 447105XG

PackagingBox of 100 glovesCarton of 10 boxes

PackagingBox of 50 glovesCarton of 20 boxes

PackagingBox of 100 glovesCarton of 10 boxes

Product codesXS: 447003XPS: 447003M: 447004L: 447005XL: 447005XG

Classifi cationNon-sterile vinyl examination gloves are non-reusable and are intended for medical use for cross-contamination protectionof the patient and user. They are to be considered "non-invasiveor invasive medical devices for temporary or short-term use"within the meaning of the European directive concerned, and as such are Class I.

Vinyl examination glove, non-sterile, powder-free, ambidextrous, standard cuff minimum 240 mm

Vinyl examination glove, non-sterile, powder-free, ambidextrous, extra-long cuff minimum 290 mm

Stretch vinyl examination glove,non-sterile, powder-free, ambidextrous, standard cuff minimum 240 mm

Product codesS: 447009M: 447010L: 447011(XS and XL on request)

DescriptionThis examination glove is ambidextrous, non-sterile,powder-free, and is made of polyvinyl chloride. Its surface is smooth, the standard vinyl glove is transparent and the stretch vinyl glove is white, and its beaded cuffcomes in a standard length of minimum 240 mm orextra-long length of minimum 290 mm.

DraculaWall mountUniversal box holder(wall mount with screws ordouble-sided adhesive)> Carton of 50 units> Product code: 090002

Composition (PVC and chemical agents)

Technical specifi cations

Manufacturing process (summary)

Formulation of Exanyl® gloves Formulation of Exasyntil® glovesPVC (Polyvinyl Chloride Resin), DOTP (Dioctyl terephthalate),TXIB (2,2,4-trimethyl-1,3-pentanediol diisobutyrate),Polyurethane Emulsion (Component a: Polyurethane,Component b: Polysiloxane, Component c: Silica), AliphaticHydrocarbon, Organic Hydrocarbon, Ca-Zn stabilizer (Calciumstearate, Zinc stearate)

PVC (Polyvinyl Chloride Resin), DOTP (Dioctyl terephthalate), TXIB(2,2,4-trimethyl-1,3-pentanediol disobutyrate), Polyurethane Emulsion (Component a: Polyurethane, Component b: Polysiloxane, Component c: Silica), Aliphatic Hydrocarbon, Organic Hydrocarbon, Ca-Zn stabilizer (Calcium stearate, Zinc stearate), Elastomer (Adipic Acid Ester) Pigment White (Titanium dioxide, Diisononyl phthalate)

N.B. - Do not contain Di-(2-ethylhexyl) Phthalate (DEHP) and Dibutyl Phthalate (DBP). Do not contain latex, and no animal derivatives.

N.B. - Testing reports and quality certifi cates on request.

N.B. - Inspections and sampling plans all alongthese steps according to Quality System process.

Raw materials reception and inspection

Final shipping

Composition of the mixture

Plastic coatingVinyl dipping

GloveextractionBeading

Pre-shipmentinspection

Filtration

Soaking polyurethane

Visual inspection and selection

Deaeration

Oven drying ofthe polyurethane coating

Packing

Cleaningof forms

Storage

Criteria Standards Results Exanyl®, Exanyl Long®, Exasyntil®

DETECTION OF PINHOLES (tests and level control) EN 455-1 AQL 1.5 (Acceptance Quality Limit)

DIMENSIONS EN 455-2 length 240 mm minimum (and 290 mm min. for long)width Extra-Small: 75 5 mm - Small: 85 5 mm - Medium: 95 5 mm Large: 105 5 mm - Extra-Large: 110 5mm

FORCE AT BREAK EN 455-2before aging 3,6 N at minimumafter aging 70 2°C during 7 days 3,6 N at minimum

SHELF LIFE EN 455-4After storage of 7 days at 70° C°, and 90 days at 50°C° 3 years (recommended)

THICKNESS (SIMPLE) ASTM D5250cuff 0,08 + 0,03 mm (0,09 + 0,03 mm for long)palm 0,11 0,03 mmfi nger 0,09 0,03 mm

ULTIMATE ELONGATION ASTM D5250Before and after aging (70 2°C during 72 h + 2h) 350% minimum for vinyl & 400% minimum for stretch

GLOVES AVERAGE WEIGTH NO 4,5g 0,3 for vinyl and 5,3g 0,3 for stretch normal cuff (M) STANDARD 7g 0,3 for vinyl long cuff (M)

MANUFACTURING PLACE China

Regulatory symbolaccording to ISO 15223-1

Instructions for use and storage

V09

.17

Double certifi cation M.D./P.P.E.

Quantity, size and CE mark

Recyclablepackaging

Do not reuse single usage

Certifi edfood contact

Slight chemical resistance

Store awayfrom moisture

Store away fromsun and U.V

Resistance to micro-organisms

Readinformation

Batch number (day, month, year

of production)

Expiry date (maximum recommended date)

AcceptanceQuality Limit

Slight chemical

Store away from

micro-organisms

PACKAGINGAND MARKING

THERMOFINAZ.A.C. CHAMLYS - B.P. 13077194 DAMMARIE-LES-LYS FRANCET : 33 (0) 1 64 37 81 96 F : 33 (0) 1 64 37 08 77www.thermofi na.fr

Pallet

Carton

Box

• Complete Europe Pallet of 60 cartons or 600 boxes or 60 000 gloves (30 cartons or 30 000 gloves for LONG)• Possible mix size and/or material by multiple of 10 cartons per layer (6 cartons per layer for LONG)• Dimensions ground 0,80 x 1,20 m

• Average weight 390 kg (290 kg for LONG)• Neat loading, fi lmed labelled and circled with guarantee strip

• Returnable Europe Pallet

• Carton of 10 boxes or 1000 gloves 33 L x 24 H x 24 l approximately (20 boxes of 50 gloves for LONG 45 L x 32 H x 28 l approximately)• Identifi cation of sizes and materials by colour codes, letters and numbers

• Traceability by batch number and expiry date

• Average weight 6,3 kg (9 kg for LONG)• Recyclable material

• Possible customization on request

• Box of 100 gloves (50 gloves for LONG)• Identifi cation of sizes and materials by colour codes, letters and numbers

• Traceability by batch number and expiry date

• Average weight 630 g (450 g for LONG)• Regulatory symbols according to standards in force

• Provision of suitable box holders on request

• Possible customization on request