Protective Gloves

409

44.1 Introduction

There are both an increased occupational use of pro-tective gloves and increased interest in their protec-tive capacity against harmful chemicals as well as blood-borne infections (e.g., hepatitis, HIV), as the directives and regulations concerning the use and safety requirements for protective gloves have come in to force in Europe.

In order to select, purchase, or use protective gloves, it is necessary to obtain information on cur-rent standards, on quality requirements, nature of hazard, performance data, acceptable level of expo-sure to hazards, and the nature of dermatological adverse effects caused by protective gloves of rubber and plastics.

The information on the performance of protective gloves and other protective clothing is found in an in-creasing amount of reports in the literature. Generally, the choice of protective material may be obtained by reviewing the literature and deciding on the best suit-able material.

44.2 Field of Application—Rules and Regulations

Gloves intended for protection of the user are in Eu-rope (EU), referred to as personal protective equip-ment and covered by the Personal Protective Equip-ment Directive 89/686/EEC. The gloves intended for use in the medical field to protect patients and users from cross-contamination, on the other hand, are re-ferred to as medical devices and are covered by the Council Directive 93/42/EEC concerning medical devices [29].

In the USA a committee within ASTM (American Society of Testing and Materials), F-23 on Protective Clothing, has during the last 15 years been working with development of standards for items of protec-tive clothing, such as gloves. Another ASTM commit-tee, D-11 on Rubber, has been working with medical glove standard-setting activity since the mid-1970s. A survey of the USA rules, regulations, and standards concerning protective and medical glove use has re-cently been presented by N. Henry III [15].

44 Protective GlovesGunh A. Mellström, Anders Boman

Contents

44.1 Introduction . . . 40944.2 Field of Application—Rules

and Regulations . . . 40944.2.1 Protective Gloves . . . 41044.2.2 Medical Gloves . . . 41144.3 Risk Evaluation—Glove Selection . . . 41144.3.1 Selection Procedure for Gloves

Against Chemicals . . . 41144.3.1.1 Chemical Classification—Risk

of Skin Injury . . . 41144.3.1.2 Working Activity—Degree of Exposure . . . 41144.3.1.3 Glove Selection—Requirements . . . 41144.3.2 Selection Procedure for Gloves

Against Microorganisms . . . 41244.4 Protective Effect . . . 41244.4.1 Protection Against Microorganisms . . . 41244.4.2 Protection Against Some Chemical

Agents Hazardous to the Skin . . . 41344.4.2.1 Disinfectants . . . 41344.4.2.2 Pharmaceuticals . . . 41344.4.2.3 Composite Materials (Bone Cement,

Dental Filling Materials) . . . 41344.4.2.4 Solvents . . . 41444.4.2.5 Corrosive Agents . . . 41444.4.2.6 Detergents, Surfactants, Cleansers . . . 41444.4.2.7 Oils, Cutting Fluids, and Lubricant Oils . . . 41444.5 Limitation of Use Due to Side Effects . . . 41444.5.1 Therapeutic Alternatives . . . 41544.5.1.1 Gloves of Synthetic Materials . . . 41544.5.1.2 Double Gloving . . . 41544.5.1.3 Non-powder Gloves . . . 41544.5.1.4 Creams and Gloves . . . 41544.6 Glove Operating Instructions . . . 41544.7 Testing of the Protective Glove Barrier . . . 41544.7.1 Standard Test Methods . . . 41544.7.1.1 Physical Properties . . . 41544.7.1.2 Penetration (Leakage) . . . 41644.7.1.3 Permeation . . . 41644.7.1.4 Biocompatibility . . . 41644.7.2 Other Tests . . . 41744.8 Glove Materials and Manufacturing . . . 41744.9 Conclusions . . . 417

References . . . 418

Gunh A. Mellström, Anders Boman410

44.2.1 Protective Gloves

The EEC-Directive gives general requirements for all personal protective equipment, and requirements de-pend on the type of gloves have been described [29].

Protective gloves are classified in three categories due to intended use and attestation procedures:

Category I: Gloves of simple design—for minimal risk application

Category II: Gloves of intermediate design—for inter-mediate risk

Category III: Gloves of complex design—for irrevers-ible/mortal risks

The requirements for EC-type certification are a declaration of conformity and a technical documen-

Table 1. Protection Index based on breakthrough times determined during continuous contact with the test chemical, describe in European Standard EN 374:3

Measured breakthrough time Protection Index

>10 min Class 1

>30 min Class 2

>60 min Class 3

>120 min Class 4

>240 min Class 5

>480 min Class 6

Table 2. Examples of ASTM and EN Standards for protective gloves against chemicalsEN, European Standard, European Committee for Standardisa-tion; ASTM, American Society of Testing and Materials

Document number Title

ASTM F 739 Standard test methods for resistance of protective clothing materials to permeation by liquids and gases under conditions of continuous contact.

ASTM F 1383 Standard test method for resistance of protective clothing materials to permeation by liquids and gases under conditions of intermittent contact

ASTM F 1407 Standard test method for resistance of protective clothing materials to liquid permeation—permeation cup method

ASTM F 903 Standard test method for resis-tance of protective clothing ma-terials to penetration by liquids

EN 420 General requirements for gloves

EN 374 Protective gloves against chemi-cals and micro organisms:

Part 1 Terminology and perfor-mance requirements

Part 2 Determination of resis-tance to penetration

Part 3 Determination of resistance to permeation by chemicals

Table 3. Examples of ASTM and EN Standards for medical glovesASTM, American Society of Testing and Materials; EN, Euro-pean Standard, European Committee for Standardisation

Document number Title

ASTM D 3577 Standard specification for rub-ber surgical gloves

ASTM D 3578 Standard specification for rub-ber examination gloves

ASTM D 5151 Standard test method for detec-tion of holes in medical gloves

ASTM D 5250 Standard specification for polyvinyl chloride gloves for medical application

ASTM D 5712 Standard test method for analy-sis of protein in natural rub-ber and its products.

EN 455 Medical gloves for single use:

Part 1 Requirements and test-ing for freedom from holes

Part 2 Requirements and test-ing for physical properties.

Part 3 Requirements and testing for biological evaluation

41144 Protective Gloves

tation file for all categories of gloves. For categories II and III there are additional requirements on EC-type examination testing by approved laboratories, certi-fied by approved notified bodies, and manufacturing under a formal EC quality assurance system.

The European Standard EN 420, for protective gloves, defines general requirements for most kinds of protective gloves. Key points are fitness of purpose, innocuousness, sound construction, storage, sizing, measure of glove–hand dexterity, product informa-tion, and labeling.

Some of the EN and ASTM Standards for protec-tive gloves against chemicals are given in Table 2

44.2.2 Medical Gloves

Medical gloves for single use are gloves intended for use in the medical field to protect patients and users from cross-contamination. They are classified in cat-egories: surgical gloves, examination and/or proce-dure gloves (sterile or nonsterile), and foil film gloves. Examples of EN and ASTM Standards for medical gloves for single use are given in Table 3

44.3 Risk Evaluation—Glove Selection

44.3.1 Selection Procedure for Gloves Against Chemicals

Several factors need to be taken into account when selecting a glove for a particular application. One of the first guidelines for the selection of protective clothing, gloves included, was presented by Schwope et al. [38].

Leinster [23] has described the selection and use of gloves against chemical in a matrix model based on working activity and chemical classification. The selection procedure adapted to the EN standards for protective gloves are presented below.

44.3.1.1 Chemical Classification—Risk of Skin Injury

A. Mainly contact with chemicals less harmful and not classified as hazardous substances and requir-ing labeling. Minimal risk only for slight injuries.

B. Mainly contact with chemicals classified as toxic, harmful, or irritant. Intermediate risk for moder-ate, reversible injuries.

C. Mainly contact with chemicals classified as highly toxic, highly corrosive, corrosive and agents causing cancer, sensitization, or those absorbed through the skin. High risk for severe or irrevers-ible injuries.

44.3.1.2 Working Activity—Degree of Exposure

1. Risk of exposure, possible splashing2. Occasional, repeated (intermittent), and expected

exposure3. Continuous exposure during certain time, ex-

pected or by accident

44.3.1.3 Glove Selection—Requirements

Chemical class/Risk of skin injury

Working activity/exposure time

1 2 3

A (Category I) Category I Category II

B Category I Category II Category II

C Category I Category II Category III(Category I): Gloves not essential

Category I: Gloves of simple design should be used when the risk for skin injuries is minimal and can be identified beforehand. For example, disposable and/or reusable gloves for wet work to protect against cleaning agents and surfactants at home and in the workplace. For CE- mark, the gloves and the package should have the text: “For minimal risk only.” No test-ing of the protective effect required.

Category II: Gloves of all kind with intermediate de-sign. These gloves have neither simple nor complex designs and should be used when there is an identi-fied risk which is neither minimal nor high. For CE-marking the protective effect has to be tested and ap-proved by a certified laboratory. Breakthrough time (BT) and/or permeation rates (PR) are required. The gloves /packages should be labeled with CE-mark and a pictogram (symbol) showing the protective perfor-mance for a certain risk, e.g., chemicals and microor-ganisms, heat, cold, mechanical risks.


Category III: Gloves usually have a more complex de-sign for use in high-risk situations (emergency). They are often used as a complement to protective clothing (suit). The gloves should be tested for the intended use by a certified laboratory. BT and/or PR are re-quired and also test results relevant to the glove task. The gloves /packages should be labeled with CE-mark and a pictogram (symbol) showing the protective per-formance for a certain risk and a four digit code for the certified laboratory that performed the testing.

The Protection Index is based on BT determined during continuous contact with the tested chemical, measured with a standard method. The protection in-dex is only and always valid for the specific chemical tested (see Table 1).

Because of the diversity and numbers of chemicals used in industry there was a need for test method strategy. A list of a standard battery of test chemicals was developed (ASTM/F 1001–89: Guide for the Se-lection of Chemical to Evaluate Clothing Materials) and most glove manufacturers publish their perme-ation results with reference to this list.

44.3.2 Selection Procedure for Gloves Against Microorganisms

A scheme for the selection and use of gloves by health care personnel in different situations based on pur-pose, working procedure, type of glove (medical gloves or protective gloves), and risk of exposure to infection or micro-organism has been suggested by Burman and Fryklund [6].

• Protection of personnel from Hepatitis (A, B, C), HIV, HTLV

Surgical glove: surgeryExamination gloves, nonsterile: dentistry, risk of contact with bloodProtective gloves (e.g., domestic gloves): risk of contact with blood

• Protection of personnel and patients from various viruses and bacteria

Protective gloves: handling of feces, urine, vomit, etc.

• Protection of patients from Hepatitis, HIV, and other viruses and bacteria

Surgical glove: surgeryExamination gloves, sterile: other invasive procedures

••

•

•

••

Examination gloves, nonsterile: dentistry, iso-lation, barrier nursingProtective gloves: isolation, barrier nursing, handling of feces, urine, vomit, etc.

Fay [11] has presented a similar schedule with clinical selection criteria for the gloves in health care treatment.

44.4 Protective Effect

For most of the agents that can cause irritant derma-titis there are few investigations and studies of the glove barrier effect. In several occupations it is also more the than one specific agent that is the cause of the dermatitis, for example, in wet work of differ-ent kinds, food handling and processing, and plant maintenance. In these working situations good hand hygiene together with rubber and plastic gloves of simple or intermediate design will in most cases give satisfactory protection. The investigations of gloves' protective effect against microorganisms and some hazardous chemicals are described below.

44.4.1 Protection Against Microorganisms

Hamann and Nelson [14] reviewed a number of glove barrier studies against microorganisms performed with different kinds of test methods during the pe-riod 1976–1993. They also compared the protective barriers provided by latex and thermoplastic elasto-mer (TPE) sterile surgical gloves against penetration of the bacteriophage phi X174 as surrogate for blood-borne pathogens. They found that the TPE gloves had a mechanical barrier effect that was equal or bet-ter than that offered by the latex gloves tested. Their conclusions from the review of investigations of glove barrier properties and their own results were that the barrier effect of the gloves depends on a complex in-teraction of several factors such as:

• Type and brand of glove (latex or plastic materi-als)

• Condition of use (unused, stimulated use, or in actual clinical situations)

• Sensitivity of the assay (water-, air-, dye-leak tests, bacterial or viral penetration)

They also concluded that some trends could be seen from the data such as:

•

•

•


• The material is an important determinant of the glove barrier.

• The brand of glove influences the out come of bar-rier testing.

• The quality of a glove is more closely related to the manufacturer than to the glove material.

• Leakage rates are related to the level of use a glove receives.

• The efficacy of the glove barrier varies with the sensitivity of the testing procedure.

44.4.2 Protection Against Some Chemical Agents Hazardous to the Skin

44.4.2.1 Disinfectants

Quite a lot of disinfectants are generally used to clean surfaces and objects and to sterilize instruments. At skin disinfection and in working situations where there is a risk of acquiring blood-borne infections the use of different kinds of disinfectants is frequent. In these circumstances it is important to use gloves, both to protect the skin against infections and fre-quent contact with disinfectants harmful to the skin. Some of these agents are known to cause allergic and/or irritant reactions after contact with the skin, for ex-ample ethanol [41], isopropyl alcohol [18], chlorocre-sol [12, 13], and glutaraldehyde [34].

The influence of four disinfectants on six differ-ent brands of medical gloves by measuring the per-meation and conducting SEM studies of the exposed glove material surfaces has been described by Mell-ström et al. [30]. They found that gloves of latex, PVC, and polyethylene gave acceptable protection from contact with p-chloro-m-cresol- (Blifacid) and glu-taraldehyde- (Cidex) containing products for at least 60 min but gave only a short time of protection from contact with isopropanol and ethanol.

For risk of splashes or very short contact time (10–30 min) and for occasional but intentional expo-sure (30–60 min), thin gloves made of natural rubber, EMA, PE, and PVC can be useful. At intentional ex-posure during extended periods (>60 min) domestic gloves of natural rubber or PVC or double gloving; natural rubber with EMA, PE, or PVC as inner gloves should be used.

44.4.2.2 Pharmaceuticals

Pharmaceutical preparations of drugs, e.g., cytostatic agents have a very heterogeneous mechanism of ac-

tion; they have potent pharmacological properties and it is well known that they can cause acute skin in-juries in cases of accidental exposure [21]. The extent of health hazards due to chronic exposure to small amounts of cytostatic drugs by personnel handling these drugs is still not completely known and there-fore it is necessary to minimize the exposure. In order to minimize the exposure when preparing, dispens-ing, and administrating these drugs, standard proce-dures, appropriate techniques, and personal protec-tive equipment, e.g., gloves, should be used. However, there are no requirements or criteria for evaluating medical glove quality for this purpose of use.

The permeability of gloves to several cytostatic drugs was presented in an overview by Mellström et al. [32]. However, the procedures used were not stan-dardized methods; the analytical methods, equipment, and sensitivity varied tremendously, and therefore the test results were hard to evaluate and compare.

Three factors seem to have a crucial influence on the permeation through the lipophilic natural latex glove membrane: the pH-value (ionization), lipophi-licity, and the molecular size. Both Mitoxantrone and Carmustine (BCNU), the two drugs that permeated in less than 15 min, have low molecular weight and high lipophilicity [26]. The need for requirements of barrier effect against hazardous drugs for medi-cal gloves has been shown by Sessink et al. [40]. They studied the occupational exposure to cyclophospha-mide, 5-fluorouracil, and methotrexate in technicians involved in drug preparation. Contamination and permeation through latex gloves were found for each of the three compounds. Today there are some medi-cal gloves intended for use in handling cytostatic drugs (protective gloves by definition) and should then fulfill the requirements on permeation for pro-tective gloves (Category II) and not only require-ments on leakage for medical gloves. That means that they should have a Protection Index for the specific chemical/drug they are suppose to give protection against (see Table 1).

44.4.2.3 Composite Materials (Bone Cement,Dental Filling Materials)

The increased use of acrylic compounds as substitute for amalgam by dentists, dental nurses, and dental technicians has caused an increasing frequency of hand eczema for these groups. This is a serious and increasing problem since today there are no gloves available that allow the dexterity required and at the same time give sufficient protection to the skin. Stan-


dard procedures, appropriate technique, and packag-ing design together with adjusted personal protective gloves are highly needed.

Acrylic compounds used in orthopedic and dental surgery are well known to cause skin problems [20, 19, 35]. These compounds can also affect the barrier capacity of the glove material after only a short time of exposure.

The combined use of latex gloves with the 4H-gloves as an inner glove can be useful in some work-ing situations.

Double gloving and frequent exchange of gloves is recommended if there is no Protection Index avail-able for any glove.

44.4.2.4 Solvents

Alcohols and other aliphatic and aromatic organic solvents have a degreasing and irritating effect on the skin and can be absorbed through the skin into the blood circulation. Category I gloves made of natural rubber, PE, or PVC can be used when there is risk for splashes or for very short contact times (10–30 min).Category I or II gloves with a Protection Index for the specific chemical should be considered for use dur-ing occasional but intentional exposure (30–60 min)and during intentional exposure for extended peri-ods (>60 min). Gloves made of nitrile rubber, natural rubber, neoprene rubber, 4H-glove, Viton, or butyl rubber should be used.

44.4.2.5 Corrosive Agents

Corrosive substances such as oxidizing/reducing agents, acids, bases, and concentrated salt solutions can, after contact with small amounts but during short, repeated exposure or extended exposure, cause severe irritation to the skin.

Category I gloves made of natural rubber, PE, and PVC are suitable for work with or at risk for exposure to these kinds of hazardous chemicals only for a very short contact time (10–30 min). Category II gloves with a Protection Index should be considered for use at occasional but intentional exposure (30–60 min)and at intentional exposure during extended periods (>60 min). Gloves made of neoprene, natural or ni-trile rubber can be useful as well as butyl rubber, Vi-ton, or the 4H glove.

44.4.2.6 Detergents, Surfactants, Cleansers

Washing up-liquids, cleaning agents, and soaps are usually water based and when used in recommended concentrations there are only mild effects on the skin; however, used in too high a concentration they can cause skin injuries. Sometimes organic solvents like white spirit or isopropanol are added. Category I gloves suitable for work at risk for splashes or with very short contact time (10–30 min) can be made of EMA, PE, or PVC. Category I or II gloves with a Protection Index should be considered for use at oc-casional but intentional exposure (30–60 min) and at intentional exposure during extended periods (>60 min). Gloves made of natural rubber, neoprene, or PVC can be useful. If organic solvent is an ingredi-ent, then the use gloves made of nitrile rubber is an alternative.

44.4.2.7 Oils, Cutting Fluids, and Lubricant Oils

These agents often contain anticorrosive agents, bacte-ricides, and antioxidants. Used oils can contain small amounts of chromium, nickel and cobalt. Category I gloves suitable for work at risk for splashes or with very short contact time (10–30 min) can be made of natural rubber or PVC. Category I or II gloves with a Protection Index should be considered for use at occasional but intentional exposure (30–60 min)and at intentional exposure during extended periods (>60 min). Industrial gloves made of nitrile rubber, natural rubber, or neoprene can be useful gloves as well as 4H gloves or nitrile rubber gloves.

Warning! When working at machinery with rotat-ing parts, gloves can imply a risk of tear injury.

44.5 Limitation of Use Due to Side Effects

Some common causes of side effects by glove users:

• Allergic reactions to gloves can be caused by, e.g., rubber chemicals, organic pigments, latex pro-teins, glove powder, chromate in leather gloves.

• Irritant reactions to gloves, e.g., mechanical stress, occlusion, sweating, maceration, endotoxins, eth-ylene dioxide, glove powder

• Side effects due to glove powder, e.g., starch-in-duced adhesions, granulomas following surgery


44.5.1 Therapeutic Alternatives

The occupational groups that most frequently are af-fected by contact dermatitis and contact urticaria due to rubber (latex) gloves are cleaning personnel, food industry workers (manufacturing, cooking), and all kinds of health care employees [9, 10, 27]. Utilizing gloves of alternative materials will minimize the risk of adverse effects in persons sensitive to latex rubber proteins and is strongly recommended.

44.5.1.1 Gloves of Synthetic Materials

Gloves of plastic polymer materials are necessary to use both in the treatment of patients and by those employees with a known allergy to latex proteins. They reduce the risk for contact dermatitis caused by rubber additives as well as for contact urticaria by latex proteins. Gloves of polymer materials are also necessary for use by those employees with a known allergy to chromate in leather gloves.

44.5.1.2 Double Gloving

• Natural rubber latex gloves and inner gloves of plastic material, nylon, or cotton reduce the risk of contact dermatitis and urticaria caused by latex rubber gloves.

• Natural rubber latex gloves and synthetic fiber gloves reduce the risk of cut and puncture inju-ries.

• Natural rubber latex gloves and latex or plastic gloves reduce the risk of blood-borne infections and/or chemical permeation.

44.5.1.3 Non-powder Gloves

Powder-free gloves should be used to reduce the risk of symptoms like rhinitis, conjunctivitis, and asthma caused by glove powder contaminated by latex pro-teins.

44.5.1.4 Creams and Gloves

Allmers [1] has recently shown that the combined use of skin care cream and latex gloves may hamper the uptake of allergens from latex gloves and reduces the risk for side effects from latex gloves.

44.6 Glove Operating Instructions

• Reusable gloves should be for personal use only.• Reusable gloves should be decontaminated before

they are removed.• The decontamination procedure used will depend

on the chemical.• Reusable gloves should not be left, when not being

used, where they are likely to be contaminated.• Persons who experience hand sweating should

have several pairs of gloves available.• Disposable/single-use gloves can be removed by

peeling the glove inside out.• Gloves contaminated on the inside should be

thrown away.• Gloves used in contact with solvents should be ex-

changed several times a week

44.7 Testing of the Protective Glove Barrier

If protective gloves and medical gloves for single use are to give an adequate level of protection, different properties must be tested and evaluated.

44.7.1 Standard Test Methods

44.7.1.1 Physical Properties

In the EN and ASTM standard specifications, require-ments and test methods are given, such as sampling and selection of test pieces; physical dimensions with length, strength, and thickness; and load for break before and after accelerating aging. The barrier ef-fect is also affected by storage conditions; this is most important for medical gloves made of natural rubber latex.

In the British Standard (BS 3574:1989) the fol-lowing guidelines and requirements for storage are given:

• The gloves should be kept in the original trans-portation or ward package and the storage tem-perature should be below 25C°.

• The relative humidity of the air may not be so high that there is condensation.

• The gloves should be stored in the dark, protected from the sun and the light from fluorescent tubes, and not be stored near any source yielding ion-ized radiation, e.g., an X-ray apparatus.


44.7.1.2 Penetration (Leakage)

The penetration of chemicals and/or microorganisms is a process which can be defined as the flow through closures, porous materials, seams, and pinholes or other imperfections in a protective or medical glove material and on a nonmolecular level. Leakage can lead to uncontrolled contact to hazardous chemicals or infectious materials, especially in the health care field. Penetration test methods for protective gloves and leakage testing for medical gloves has been de-scribed by Mellström et al. [31]. Leakage tests as a rule include a random sampling procedure where a certain number of gloves are filled with a specified volume of water or air. These are pass/fail tests and the number of gloves that fail out of the number of gloves tested depends on the batch or lot size. A sam-pling procedure for inspection by attributes is defined by the International Organisation for Standardisation (ISO 2859) Examples of some ASTM and EN stan-dard test methods for penetration/leakage testing are presented in Tables 2 and 3.

There are several standardized leakage test meth-ods designed for medical gloves that have been evalu-ated; all test methods had inherent limitations [7]. Standard quality control testing and virus penetration testing have recently been presented in an overview by Lytle et al. [25]. The standard tests for glove in-tegrity and the virus penetration testing (employing used and intact gloves as well as penetration through punctures in gloves) are discussed. The tests used for evaluation of the barrier integrity fall into two catego-ries:

• Those intended to assure quality during and after manufacturing, and

• Those tests which imply challenging the barrier with viral or chemical agents.

They concluded that viral challenges to gloves in-dicated that latex gloves provided significant barrier protection against very small viruses, and that appar-ent barrier integrity cannot assure safety, but current quality control protocols assure that medical gloves provide significant protection.

44.7.1.3 Permeation

Permeation is usually described as the process by which a chemical migrates through the protective clothing material on a molecular level, including sorption, diffusion, and desorption processes. Per-meation test methods for protective gloves have been

described by Mellström et al. [31]. The principle of permeation standard testing is a flow-through sys-tem where a two-compartment permeation cell of standard dimensions is used. The test specimen act as an barrier between the first compartment which contains the test chemical and the second compart-ment through which a stream of the collecting me-dium (gas or liquid) is passed for the collection of dif-fused molecules of the test chemical or its component chemicals for analysis. The key parameters measured are usually:

• Breakthrough time (BT, min). Both in the ASTM and EN standard test methods, BT is defined as the time when a specified permeation rate is reached.

• Permeation rate (PR), i.e., the mass of test chemi-cal permeating the material per unit time per unit area (µg/min cm2)

• Steady-state permeation (SP), i.e., a state that is reached when the permeation rate becomes virtu-ally constant.

In the European Standard for protective gloves against chemicals and microorganisms, one of the requirements is that the protective effect of a certain combination of protective glove/test chemical should be presented as a Protection Index.

• Protection Index is based on BT measure at con-stant contact with the test chemical (European Standard EN 374: part 1,1994; see Table 1).

44.7.1.4 Biocompatibility

In recent years there have been increased problems with severe adverse reactions in health care workers caused by latex products, e.g., latex proteins in gloves. Also, adverse reactions due to rubber chemicals, pow-der, lubricants, endotoxins, and pyrogens are well known and more frequent than reactions to proteins. To date there is not yet any complete agreement on methods of measurements and control of these aller-gens. However, in the European Standard the require-ments and test methods for biological evaluation for medical glove use have been recommended in the EN 455: Medical gloves for single use.

At the ASTM work is also in progress to develop requirements and standardized test methods for those chemicals that are clearly associated with allergic reactions as well as for determination of allergenically relevant natural rubber latex proteins (see Table 3).


44.7.2 Other Tests

Additional information on protective efficacy of gloves can be derived from in vivo testing in man or in experimental animals [2, 3].

In work-related testing the concentration of the chemical or its metabolites is measured in blood, urine, or other body fluids after exposure in the ac-tual working situation with and without protective gloves [5, 16, 22, 40].

The protective effects as well as side effects of gloves can be studied by patch testing, with the specific chemical together with pieces of glove. The results are read as the difference in reactivity between protected and unprotected skin. The patch test method may be used when no data on permeation are available [24].

All these tests are mainly used for testing the pro-tective effect against allergens but can in exceptional cases be used for testing with irritant chemicals.

44.8 Glove Materials and Manufacturing

The materials used for manufacturing of protective gloves are natural rubber, synthetic rubber, textile fibers, leather, and several polymeric materials (see Table 4). Mellström and Boman [28] presented man-ufacturing methods and glove types and a detailed description of the materials used for gloves. The pro-tective effect of different glove materials against haz-ardous chemicals depends on the following factors:

Thickness:• ΒΤ increases as the thickness of the glove material

increases but in a nonlinear fashion [17, 39].

Material composition:• The quality and protective effect of gloves of the

same material can differ due to manufacturing processes, variation in polymer formulation, ad-ditives, and quality control procedure [28, 36].

• The barrier effect of different generic materials is quite variable. Each combination of chemical and protective glove material has to be considered [33, 37].

44.9 Conclusions

Factors of importance that have to be considered in the selection procedure are:

• The resistance to penetration and permeation of hazardous chemicals and microorganisms

• Risk of adverse effects when using a specific glove (allergic contact dermatitis, contact urticaria, ir-ritation, itching, etc.)

• Mechanical quality of the glove material (tensile strength; dexterity; cut, tear, and puncture resis-tance)

• Function, the gloves must not imply another risk or be a hindrance

• Comfort, the right size, pleasant to wear• Quality uniformity, a moderate price

All these factors show that the selection procedure can be complicated indeed.

Table 4. Survey of glove materials used for protective (PG) and medical gloves (MG)PG, protective glove; MG, medical glove for single use

Material name/Trade Names Abbre-viation

Intended use

Natural rubber (Latex) NR PG and MG

Synthetic rubber materials

Butyl rubber BR PG

Chloroprene/Neoprene NE PG and MG

Fluor rubber/Viton V PG

Nitrile rubber/Nitrilite, N-Dex NI PG

Styrene-butadiene/Elastyren MG

Styrene-ethylene-butadiene/Tactylon MG

Plastic polymeric materials

EMA (ethylene-methylacrylate) EMA PG and MG

Polyethylene, polythene PE PG and MG

Polyvinyl alcohol PVA PG

Polyvinyl chloride PVC PG and MG

PE/EVAL/PE, laminate/4H-glove 4H PG

Leather PG

Textile: PG

Cotton, nylon, jersey PG, inner gloves

Special Fibre materials/Kev-lar, Lycra and Spectra Fibre

Used in jersey, sur-gical inner gloves, cut resistant


References

1. Allmers H. Wearing test with 2 different type of latex gloves with and without the use of a skin protection cream. Contact Dermatitis 2001; 44:30–33

2. Boman AS, Mellström GA. Percutaneous absorption of three organic solvents in the guinea pig. IV. Effect of pro-tective gloves. Contact Dermatitis 1989; 21:260–266

3. Boman AS, Mellström GA. Percutaneous absorption stud-ies in animals. In: Mellström GA, Wahlberg JE, Maibach HI (eds) Protective gloves for occupational use. CRC Press, Boca Raton, FL, 1994; pp 91–107

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Table 5. Examples of glove materials and the protective effect against some chemicals known as irritants*Abbreviations see Table 4.

Chemical name Breakthrough time (min)/Glove material*

60<BT 60 ≥ BT ≤ 240 240 ≥ BT ≤ 480

Glutaraldehyde PVA PVC BR, NE, V

Diethanolamine NR BR, NE, NI, PVC, V, 4H

Ethanolamine NR, PVA, PVC BR, NE, NI, V,4H

Isopropylamine NR, NE, NI, PVC, V

Triethanolamine BR, NE, NI, PVA, PVC, V

Heamethyldisilazane (HMDZ) NR, NE, PVC

Di-n-butylphtalate NR, PVC NE BR, NI, PVA, V

Diethylphtalate 4H

1,4-Butanediol diglycidyl ether 4H

Benzyl alcohol NR, NI, PVC BR V, 4H

Ethylene glycol PVA BR, NR, NE, NI, PE, PVC,V,4H

Furan BR, NR, NE, NI, PVC PVA, V

N-Methyl 2-pyrrolidone (NPM) NE, NI, PVA, PVC, V NR BR, 4H

Tetrafluorethylene BR, NE, PVA, V

Tetramethylenediamine (TMEDA) BR, NR, NE, NR, PVC, V


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