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409

44 Protective Gloves
Gunh A. Mellström, Anders Boman

Contents 44.1 Introduction


44.1 Introduction . . . 409 There are both an increased occupational use of pro-
44.2 Field of Application—Rules
tective gloves and increased interest in their protec-
and Regulations . . . 409
tive capacity against harmful chemicals as well as
44.2.1 Protective Gloves . . . 410
blood-borne infections (e.g., hepatitis, HIV), as the
44.2.2 Medical Gloves . . . 411
directives and regulations concerning the use and
44.3 Risk Evaluation—Glove Selection . . . 411
safety requirements for protective gloves have come
44.3.1 Selection Procedure for Gloves
Against Chemicals . . . 411
in to force in Europe.
44.3.1.1 Chemical Classification—Risk In order to select, purchase, or use protective
of Skin Injury . . . 411 gloves, it is necessary to obtain information on cur-
44.3.1.2 Working Activity—Degree of Exposure . . . 411 rent standards, on quality requirements, nature of
44.3.1.3 Glove Selection—Requirements . . . 411 hazard, performance data, acceptable level of expo-
44.3.2 Selection Procedure for Gloves sure to hazards, and the nature of dermatological
Against Microorganisms . . . 412 adverse effects caused by protective gloves of rubber
44.4 Protective Effect . . . 412 and plastics.
44.4.1 Protection Against Microorganisms . . . 412 The information on the performance of protective
44.4.2 Protection Against Some Chemical gloves and other protective clothing is found in an in-
Agents Hazardous to the Skin . . . 413 creasing amount of reports in the literature. Generally,
44.4.2.1 Disinfectants . . . 413 the choice of protective material may be obtained by
44.4.2.2 Pharmaceuticals . . . 413 reviewing the literature and deciding on the best suit-
44.4.2.3 Composite Materials (Bone Cement, able material.
Dental Filling Materials) . . . 413
44.4.2.4 Solvents . . . 414
44.4.2.5 Corrosive Agents . . . 414 44.2 Field of Application—
44.4.2.6 Detergents, Surfactants, Cleansers . . . 414
Rules and Regulations
44.4.2.7 Oils, Cutting Fluids, and Lubricant Oils . . . 414
44.5 Limitation of Use Due to Side Effects . . . 414
Gloves intended for protection of the user are in Eu-
44.5.1 Therapeutic Alternatives . . . 415
rope (EU), referred to as personal protective equip-
44.5.1.1 Gloves of Synthetic Materials . . . 415
ment and covered by the Personal Protective Equip-
44.5.1.2 Double Gloving . . . 415
44.5.1.3 Non-powder Gloves . . . 415
ment Directive 89/686/EEC. The gloves intended for
44.5.1.4 Creams and Gloves . . . 415
use in the medical field to protect patients and users
44.6 Glove Operating Instructions . . . 415 from cross-contamination, on the other hand, are re-
44.7 Testing of the Protective Glove Barrier . . . 415 ferred to as medical devices and are covered by the
44.7.1 Standard Test Methods . . . 415 Council Directive 93/42/EEC concerning medical
44.7.1.1 Physical Properties . . . 415 devices [29].
44.7.1.2 Penetration (Leakage) . . . 416 In the USA a committee within ASTM (American
44.7.1.3 Permeation . . . 416 Society of Testing and Materials), F-23 on Protective
44.7.1.4 Biocompatibility . . . 416 Clothing, has during the last 15 years been working
44.7.2 Other Tests . . . 417 with development of standards for items of protec-
44.8 Glove Materials and Manufacturing . . . 417 tive clothing, such as gloves. Another ASTM commit-
44.9 Conclusions . . . 417 tee, D-11 on Rubber, has been working with medical
References . . . 418 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].
410 Gunh A. Mellström, Anders Boman

Table 1. Protection Index based on breakthrough Table 2. Examples of ASTM and EN Standards for protective
times determined during continuous contact with the gloves against chemicals
test chemical, describe in European Standard EN 374:3 EN, European Standard, European Committee for Standardisa-
tion; ASTM, American Society of Testing and Materials

Measured breakthrough time Protection Index Document number Title

>10 min Class 1 ASTM F 739 Standard test methods for resistance
>30 min Class 2 of protective clothing materials to
permeation by liquids and gases under
>60 min Class 3
conditions of continuous contact.
>120 min Class 4
ASTM F 1383 Standard test method for resistance
>240 min Class 5 of protective clothing materials to
>480 min Class 6 permeation by liquids and gases under
conditions of intermittent contact
Table 3. Examples of ASTM and EN Standards for medical ASTM F 1407 Standard test method for resistance of
gloves protective clothing materials to liquid
ASTM, American Society of Testing and Materials; EN, Euro- permeation—permeation cup method
pean Standard, European Committee for Standardisation ASTM F 903 Standard test method for resis-
Document number Title tance of protective clothing ma-
terials to penetration by liquids
EN 420 General requirements for gloves
ASTM D 3577 Standard specification for rub-
ber surgical gloves EN 374 Protective gloves against chemi-
cals and micro organisms:
ASTM D 3578 Standard specification for rub-
ber examination gloves Part 1 Terminology and perfor-
mance requirements
ASTM D 5151 Standard test method for detec-
tion of holes in medical gloves Part 2 Determination of resis-
tance to penetration
ASTM D 5250 Standard specification for polyvinyl
chloride gloves for medical application Part 3 Determination of resistance to
permeation by chemicals
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

44.2.1 Protective Gloves

The EEC-Directive gives general requirements for all Category II: Gloves of intermediate design—for inter-
personal protective equipment, and requirements de- mediate risk
pend on the type of gloves have been described [29].
Protective gloves are classified in three categories Category III: Gloves of complex design—for irrevers-
due to intended use and attestation procedures: ible/mortal risks

Category I: Gloves of simple design—for minimal The requirements for EC-type certification are a
risk application declaration of conformity and a technical documen-
44 Protective Gloves 411

tation file for all categories of gloves. For categories II B. Mainly contact with chemicals classified as toxic,
and III there are additional requirements on EC-type harmful, or irritant. Intermediate risk for moder-
examination testing by approved laboratories, certi- ate, reversible injuries.
fied by approved notified bodies, and manufacturing C. Mainly contact with chemicals classified as highly
under a formal EC quality assurance system. toxic, highly corrosive, corrosive and agents
The European Standard EN 420, for protective causing cancer, sensitization, or those absorbed
gloves, defines general requirements for most kinds through the skin. High risk for severe or irrevers-
of protective gloves. Key points are fitness of purpose, ible injuries.
innocuousness, sound construction, storage, sizing,
measure of glove–hand dexterity, product informa-
tion, and labeling. 44.3.1.2 Working Activity—Degree of Exposure
Some of the EN and ASTM Standards for protec-
tive gloves against chemicals are given in Table 2 1. Risk of exposure, possible splashing
2. Occasional, repeated (intermittent), and expected
exposure
44.2.2 Medical Gloves 3. Continuous exposure during certain time, ex-
pected or by accident
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- 44.3.1.3 Glove Selection—Requirements
egories: surgical gloves, examination and/or proce-
dure gloves (sterile or nonsterile), and foil film gloves. Chemical class/ Working activity/exposure time
Risk of skin injury
Examples of EN and ASTM Standards for medical
gloves for single use are given in Table 3 1 2 3
A (Category I) Category I Category II
B Category I Category II Category II
44.3 Risk Evaluation—
C Category I Category II Category III
Glove Selection
(Category I): Gloves not essential
44.3.1 Selection Procedure for Gloves
Against Chemicals Category I: Gloves of simple design should be used
when the risk for skin injuries is minimal and can
Several factors need to be taken into account when be identified beforehand. For example, disposable
selecting a glove for a particular application. One and/or reusable gloves for wet work to protect against
of the first guidelines for the selection of protective cleaning agents and surfactants at home and in the
clothing, gloves included, was presented by Schwope workplace. For CE- mark, the gloves and the package
et al. [38]. should have the text: “For minimal risk only.” No test-
Leinster [23] has described the selection and use ing of the protective effect required.
of gloves against chemical in a matrix model based
on working activity and chemical classification. The Category II: Gloves of all kind with intermediate de-
selection procedure adapted to the EN standards for sign. These gloves have neither simple nor complex
protective gloves are presented below. 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-
44.3.1.1 Chemical Classification— proved by a certified laboratory. Breakthrough time
Risk of Skin Injury (BT) and/or permeation rates (PR) are required. The
gloves /packages should be labeled with CE-mark and
A. Mainly contact with chemicals less harmful and a pictogram (symbol) showing the protective perfor-
not classified as hazardous substances and requir- mance for a certain risk, e.g., chemicals and microor-
ing labeling. Minimal risk only for slight injuries. ganisms, heat, cold, mechanical risks.
412 Gunh A. Mellström, Anders Boman

Category III: Gloves usually have a more complex de- • Examination gloves, nonsterile: dentistry, iso-
sign for use in high-risk situations (emergency). They lation, barrier nursing
are often used as a complement to protective clothing • Protective gloves: isolation, barrier nursing,
(suit). The gloves should be tested for the intended handling of feces, urine, vomit, etc.
use by a certified laboratory. BT and/or PR are re- •
quired and also test results relevant to the glove task. Fay [11] has presented a similar schedule with
The gloves /packages should be labeled with CE-mark clinical selection criteria for the gloves in health care
and a pictogram (symbol) showing the protective per- treatment.
formance for a certain risk and a four digit code for
the certified laboratory that performed the testing.
44.4 Protective Effect
The Protection Index is based on BT determined
during continuous contact with the tested chemical, For most of the agents that can cause irritant derma-
measured with a standard method. The protection in- titis there are few investigations and studies of the
dex is only and always valid for the specific chemical glove barrier effect. In several occupations it is also
tested (see Table 1). more the than one specific agent that is the cause of
Because of the diversity and numbers of chemicals the dermatitis, for example, in wet work of differ-
used in industry there was a need for test method ent kinds, food handling and processing, and plant
strategy. A list of a standard battery of test chemicals maintenance. In these working situations good hand
was developed (ASTM/F 1001–89: Guide for the Se- hygiene together with rubber and plastic gloves of
lection of Chemical to Evaluate Clothing Materials) simple or intermediate design will in most cases give
and most glove manufacturers publish their perme- satisfactory protection. The investigations of gloves'
ation results with reference to this list. protective effect against microorganisms and some
hazardous chemicals are described below.

44.3.2 Selection Procedure for Gloves


Against Microorganisms 44.4.1 Protection Against
Microorganisms
A scheme for the selection and use of gloves by health
care personnel in different situations based on pur- Hamann and Nelson [14] reviewed a number of glove
pose, working procedure, type of glove (medical barrier studies against microorganisms performed
gloves or protective gloves), and risk of exposure to with different kinds of test methods during the pe-
infection or micro-organism has been suggested by riod 1976–1993. They also compared the protective
Burman and Fryklund [6]. barriers provided by latex and thermoplastic elasto-
mer (TPE) sterile surgical gloves against penetration
• Protection of personnel from Hepatitis (A, B, C), of the bacteriophage phi X174 as surrogate for blood-
HIV, HTLV borne pathogens. They found that the TPE gloves
• Surgical glove: surgery had a mechanical barrier effect that was equal or bet-
• Examination gloves, nonsterile: dentistry, risk ter than that offered by the latex gloves tested. Their
of contact with blood conclusions from the review of investigations of glove
• Protective gloves (e.g., domestic gloves): risk barrier properties and their own results were that the
of contact with blood barrier effect of the gloves depends on a complex in-
teraction of several factors such as:
• Protection of personnel and patients from various
viruses and bacteria • Type and brand of glove (latex or plastic materi-
• Protective gloves: handling of feces, urine, als)
vomit, etc. • Condition of use (unused, stimulated use, or in
actual clinical situations)
• Protection of patients from Hepatitis, HIV, and • Sensitivity of the assay (water-, air-, dye-leak tests,
other viruses and bacteria bacterial or viral penetration)
• Surgical glove: surgery
• Examination gloves, sterile: other invasive They also concluded that some trends could be seen
procedures from the data such as:
44 Protective Gloves 413

• The material is an important determinant of the tion; they have potent pharmacological properties
glove barrier. and it is well known that they can cause acute skin in-
• The brand of glove influences the out come of bar- juries in cases of accidental exposure [21]. The extent
rier testing. of health hazards due to chronic exposure to small
• The quality of a glove is more closely related to the amounts of cytostatic drugs by personnel handling
manufacturer than to the glove material. these drugs is still not completely known and there-
• Leakage rates are related to the level of use a glove fore it is necessary to minimize the exposure. In order
receives. to minimize the exposure when preparing, dispens-
• The efficacy of the glove barrier varies with the ing, and administrating these drugs, standard proce-
sensitivity of the testing procedure. dures, appropriate techniques, and personal protec-
tive equipment, e.g., gloves, should be used. However,
there are no requirements or criteria for evaluating
44.4.2 Protection Against Some Chemical medical glove quality for this purpose of use.
Agents Hazardous to the Skin The permeability of gloves to several cytostatic
drugs was presented in an overview by Mellström et
44.4.2.1 Disinfectants al. [32]. However, the procedures used were not stan-
dardized methods; the analytical methods, equipment,
Quite a lot of disinfectants are generally used to clean and sensitivity varied tremendously, and therefore the
surfaces and objects and to sterilize instruments. At test results were hard to evaluate and compare.
skin disinfection and in working situations where Three factors seem to have a crucial influence on
there is a risk of acquiring blood-borne infections the permeation through the lipophilic natural latex
the use of different kinds of disinfectants is frequent. glove membrane: the pH-value (ionization), lipophi-
In these circumstances it is important to use gloves, licity, and the molecular size. Both Mitoxantrone and
both to protect the skin against infections and fre- Carmustine (BCNU), the two drugs that permeated
quent contact with disinfectants harmful to the skin. in less than 15 min, have low molecular weight and
Some of these agents are known to cause allergic and/ high lipophilicity [26]. The need for requirements
or irritant reactions after contact with the skin, for ex- of barrier effect against hazardous drugs for medi-
ample ethanol [41], isopropyl alcohol [18], chlorocre- cal gloves has been shown by Sessink et al. [40]. They
sol [12, 13], and glutaraldehyde [34]. studied the occupational exposure to cyclophospha-
The influence of four disinfectants on six differ- mide, 5-fluorouracil, and methotrexate in technicians
ent brands of medical gloves by measuring the per- involved in drug preparation. Contamination and
meation and conducting SEM studies of the exposed permeation through latex gloves were found for each
glove material surfaces has been described by Mell- of the three compounds. Today there are some medi-
ström et al. [30]. They found that gloves of latex, PVC, cal gloves intended for use in handling cytostatic
and polyethylene gave acceptable protection from drugs (protective gloves by definition) and should
contact with p-chloro-m-cresol- (Blifacid) and glu- then fulfill the requirements on permeation for pro-
taraldehyde- (Cidex) containing products for at least tective gloves (Category II) and not only require-
60 min but gave only a short time of protection from ments on leakage for medical gloves. That means that
contact with isopropanol and ethanol. they should have a Protection Index for the specific
For risk of splashes or very short contact time chemical/drug they are suppose to give protection
(10–30 min) and for occasional but intentional expo- against (see Table 1).
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 44.4.2.3 Composite Materials (Bone Cement,
gloves of natural rubber or PVC or double gloving; Dental Filling Materials)
natural rubber with EMA, PE, or PVC as inner gloves
should be used. The increased use of acrylic compounds as substitute
for amalgam by dentists, dental nurses, and dental
technicians has caused an increasing frequency of
44.4.2.2 Pharmaceuticals hand eczema for these groups. This is a serious and
increasing problem since today there are no gloves
Pharmaceutical preparations of drugs, e.g., cytostatic available that allow the dexterity required and at the
agents have a very heterogeneous mechanism of ac- same time give sufficient protection to the skin. Stan-
414 Gunh A. Mellström, Anders Boman

dard procedures, appropriate technique, and packag- 44.4.2.6 Detergents, Surfactants, Cleansers
ing design together with adjusted personal protective
gloves are highly needed. Washing up-liquids, cleaning agents, and soaps are
Acrylic compounds used in orthopedic and dental usually water based and when used in recommended
surgery are well known to cause skin problems [20, concentrations there are only mild effects on the skin;
19, 35]. These compounds can also affect the barrier however, used in too high a concentration they can
capacity of the glove material after only a short time cause skin injuries. Sometimes organic solvents like
of exposure. white spirit or isopropanol are added. Category I
The combined use of latex gloves with the 4H- gloves suitable for work at risk for splashes or with
gloves as an inner glove can be useful in some work- very short contact time (10–30 min) can be made
ing situations. of EMA, PE, or PVC. Category I or II gloves with a
Double gloving and frequent exchange of gloves is Protection Index should be considered for use at oc-
recommended if there is no Protection Index avail- casional but intentional exposure (30–60 min) and
able for any glove. 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-
44.4.2.4 Solvents ent, then the use gloves made of nitrile rubber is an
alternative.
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 44.4.2.7 Oils, Cutting Fluids, and Lubricant Oils
blood circulation. Category I gloves made of natural
rubber, PE, or PVC can be used when there is risk for These agents often contain anticorrosive agents, bacte-
splashes or for very short contact times (10–30 min). ricides, and antioxidants. Used oils can contain small
Category I or II gloves with a Protection Index for the amounts of chromium, nickel and cobalt. Category I
specific chemical should be considered for use dur- gloves suitable for work at risk for splashes or with
ing occasional but intentional exposure (30–60 min) very short contact time (10–30 min) can be made of
and during intentional exposure for extended peri- natural rubber or PVC. Category I or II gloves with
ods (>60 min). Gloves made of nitrile rubber, natural a Protection Index should be considered for use at
rubber, neoprene rubber, 4H-glove, Viton, or butyl occasional but intentional exposure (30–60 min)
rubber should be used. and at intentional exposure during extended periods
(>60 min). Industrial gloves made of nitrile rubber,
natural rubber, or neoprene can be useful gloves as
44.4.2.5 Corrosive Agents well as 4H gloves or nitrile rubber gloves.
Warning! When working at machinery with rotat-
Corrosive substances such as oxidizing/reducing ing parts, gloves can imply a risk of tear injury.
agents, acids, bases, and concentrated salt solutions
can, after contact with small amounts but during
short, repeated exposure or extended exposure, cause 44.5 Limitation of Use Due
severe irritation to the skin. to Side Effects
Category I gloves made of natural rubber, PE, and
PVC are suitable for work with or at risk for exposure Some common causes of side effects by glove users:
to these kinds of hazardous chemicals only for a very
short contact time (10–30 min). Category II gloves • Allergic reactions to gloves can be caused by, e.g.,
with a Protection Index should be considered for use rubber chemicals, organic pigments, latex pro-
at occasional but intentional exposure (30–60 min) teins, glove powder, chromate in leather gloves.
and at intentional exposure during extended periods • Irritant reactions to gloves, e.g., mechanical stress,
(>60 min). Gloves made of neoprene, natural or ni- occlusion, sweating, maceration, endotoxins, eth-
trile rubber can be useful as well as butyl rubber, Vi- ylene dioxide, glove powder
ton, or the 4H glove. • Side effects due to glove powder, e.g., starch-in-
duced adhesions, granulomas following surgery
44 Protective Gloves 415

44.5.1 Therapeutic Alternatives 44.6 Glove Operating Instructions


The occupational groups that most frequently are af- • Reusable gloves should be for personal use only.
fected by contact dermatitis and contact urticaria due • Reusable gloves should be decontaminated before
to rubber (latex) gloves are cleaning personnel, food they are removed.
industry workers (manufacturing, cooking), and all • The decontamination procedure used will depend
kinds of health care employees [9, 10, 27]. Utilizing on the chemical.
gloves of alternative materials will minimize the risk • Reusable gloves should not be left, when not being
of adverse effects in persons sensitive to latex rubber used, where they are likely to be contaminated.
proteins and is strongly recommended. • Persons who experience hand sweating should
have several pairs of gloves available.
• Disposable/single-use gloves can be removed by
44.5.1.1 Gloves of Synthetic Materials peeling the glove inside out.
• Gloves contaminated on the inside should be
Gloves of plastic polymer materials are necessary to thrown away.
use both in the treatment of patients and by those • Gloves used in contact with solvents should be ex-
employees with a known allergy to latex proteins. changed several times a week
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 44.7 Testing of the Protective Glove
necessary for use by those employees with a known Barrier
allergy to chromate in leather gloves.
If protective gloves and medical gloves for single use
are to give an adequate level of protection, different
44.5.1.2 Double Gloving properties must be tested and evaluated.

• Natural rubber latex gloves and inner gloves of


plastic material, nylon, or cotton reduce the risk 44.7.1 Standard Test Methods
of contact dermatitis and urticaria caused by latex
rubber gloves. 44.7.1.1 Physical Properties
• Natural rubber latex gloves and synthetic fiber
gloves reduce the risk of cut and puncture inju- In the EN and ASTM standard specifications, require-
ries. ments and test methods are given, such as sampling
• Natural rubber latex gloves and latex or plastic and selection of test pieces; physical dimensions with
gloves reduce the risk of blood-borne infections length, strength, and thickness; and load for break
and/or chemical permeation. 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
44.5.1.3 Non-powder Gloves latex.
In the British Standard (BS 3574:1989) the fol-
Powder-free gloves should be used to reduce the risk lowing guidelines and requirements for storage are
of symptoms like rhinitis, conjunctivitis, and asthma given:
caused by glove powder contaminated by latex pro-
teins. • The gloves should be kept in the original trans-
portation or ward package and the storage tem-
perature should be below 25C°.
44.5.1.4 Creams and Gloves • The relative humidity of the air may not be so high
that there is condensation.
Allmers [1] has recently shown that the combined use • The gloves should be stored in the dark, protected
of skin care cream and latex gloves may hamper the from the sun and the light from fluorescent tubes,
uptake of allergens from latex gloves and reduces the and not be stored near any source yielding ion-
risk for side effects from latex gloves. ized radiation, e.g., an X-ray apparatus.
416 Gunh A. Mellström, Anders Boman

44.7.1.2 Penetration (Leakage) described by Mellström et al. [31]. The principle of


permeation standard testing is a flow-through sys-
The penetration of chemicals and/or microorganisms tem where a two-compartment permeation cell of
is a process which can be defined as the flow through standard dimensions is used. The test specimen act
closures, porous materials, seams, and pinholes or as an barrier between the first compartment which
other imperfections in a protective or medical glove contains the test chemical and the second compart-
material and on a nonmolecular level. Leakage can ment through which a stream of the collecting me-
lead to uncontrolled contact to hazardous chemicals dium (gas or liquid) is passed for the collection of dif-
or infectious materials, especially in the health care fused molecules of the test chemical or its component
field. Penetration test methods for protective gloves chemicals for analysis. The key parameters measured
and leakage testing for medical gloves has been de- are usually:
scribed by Mellström et al. [31]. Leakage tests as a
rule include a random sampling procedure where a • Breakthrough time (BT, min). Both in the ASTM
certain number of gloves are filled with a specified and EN standard test methods, BT is defined as
volume of water or air. These are pass/fail tests and the time when a specified permeation rate is
the number of gloves that fail out of the number of reached.
gloves tested depends on the batch or lot size. A sam- • Permeation rate (PR), i.e., the mass of test chemi-
pling procedure for inspection by attributes is defined cal permeating the material per unit time per unit
by the International Organisation for Standardisation area (µg/min cm2)
(ISO 2859) Examples of some ASTM and EN stan- • Steady-state permeation (SP), i.e., a state that is
dard test methods for penetration/leakage testing are reached when the permeation rate becomes virtu-
presented in Tables 2 and 3. ally constant.
There are several standardized leakage test meth-
ods designed for medical gloves that have been evalu- In the European Standard for protective gloves
ated; all test methods had inherent limitations [7]. against chemicals and microorganisms, one of the
Standard quality control testing and virus penetration requirements is that the protective effect of a certain
testing have recently been presented in an overview combination of protective glove/test chemical should
by Lytle et al. [25]. The standard tests for glove in- be presented as a Protection Index.
tegrity and the virus penetration testing (employing
used and intact gloves as well as penetration through • Protection Index is based on BT measure at con-
punctures in gloves) are discussed. The tests used for stant contact with the test chemical (European
evaluation of the barrier integrity fall into two catego- Standard EN 374: part 1,1994; see Table 1).
ries:

• Those intended to assure quality during and after 44.7.1.4 Biocompatibility


manufacturing, and
• Those tests which imply challenging the barrier In recent years there have been increased problems
with viral or chemical agents. with severe adverse reactions in health care workers
caused by latex products, e.g., latex proteins in gloves.
They concluded that viral challenges to gloves in- Also, adverse reactions due to rubber chemicals, pow-
dicated that latex gloves provided significant barrier der, lubricants, endotoxins, and pyrogens are well
protection against very small viruses, and that appar- known and more frequent than reactions to proteins.
ent barrier integrity cannot assure safety, but current To date there is not yet any complete agreement on
quality control protocols assure that medical gloves methods of measurements and control of these aller-
provide significant protection. 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
44.7.1.3 Permeation 455: Medical gloves for single use.
At the ASTM work is also in progress to develop
Permeation is usually described as the process by requirements and standardized test methods for
which a chemical migrates through the protective those chemicals that are clearly associated with
clothing material on a molecular level, including allergic reactions as well as for determination of
sorption, diffusion, and desorption processes. Per- allergenically relevant natural rubber latex proteins
meation test methods for protective gloves have been (see Table 3).
44 Protective Gloves 417

44.7.2 Other Tests • The resistance to penetration and permeation of


hazardous chemicals and microorganisms
Additional information on protective efficacy of • Risk of adverse effects when using a specific glove
gloves can be derived from in vivo testing in man or (allergic contact dermatitis, contact urticaria, ir-
in experimental animals [2, 3]. ritation, itching, etc.)
In work-related testing the concentration of the • Mechanical quality of the glove material (tensile
chemical or its metabolites is measured in blood, strength; dexterity; cut, tear, and puncture resis-
urine, or other body fluids after exposure in the ac- tance)
tual working situation with and without protective • Function, the gloves must not imply another risk
gloves [5, 16, 22, 40]. or be a hindrance
The protective effects as well as side effects of gloves • Comfort, the right size, pleasant to wear
can be studied by patch testing, with the specific • Quality uniformity, a moderate price
chemical together with pieces of glove. The results are
read as the difference in reactivity between protected All these factors show that the selection procedure
and unprotected skin. The patch test method may be can be complicated indeed.
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.

Table 4. Survey of glove materials used for protective (PG)


44.8 Glove Materials and and medical gloves (MG)
Manufacturing PG, protective glove; MG, medical glove for single use

Material name/Trade Names Abbre- Intended


The materials used for manufacturing of protective viation use
gloves are natural rubber, synthetic rubber, textile
fibers, leather, and several polymeric materials (see Natural rubber (Latex) NR PG and MG
Table 4). Mellström and Boman [28] presented man- Synthetic rubber materials
ufacturing methods and glove types and a detailed Butyl rubber BR PG
description of the materials used for gloves. The pro-
Chloroprene/Neoprene NE PG and MG
tective effect of different glove materials against haz-
ardous chemicals depends on the following factors: Fluor rubber/Viton V PG
Nitrile rubber/Nitrilite, N-Dex NI PG
Thickness: Styrene-butadiene/Elastyren MG
• ΒΤ increases as the thickness of the glove material Styrene-ethylene-butadiene/Tactylon MG
increases but in a nonlinear fashion [17, 39].
Plastic polymeric materials

Material composition: EMA (ethylene-methylacrylate) EMA PG and MG


• The quality and protective effect of gloves of the Polyethylene, polythene PE PG and MG
same material can differ due to manufacturing Polyvinyl alcohol PVA PG
processes, variation in polymer formulation, ad- Polyvinyl chloride PVC PG and MG
ditives, and quality control procedure [28, 36].
PE/EVAL/PE, laminate/4H-glove 4H PG
• The barrier effect of different generic materials is
quite variable. Each combination of chemical and Leather PG
protective glove material has to be considered Textile: PG
[33, 37]. Cotton, nylon, jersey PG, inner
gloves
Special Fibre materials/Kev- Used in
44.9 Conclusions lar, Lycra and Spectra Fibre jersey, sur-
gical inner
Factors of importance that have to be considered in gloves, cut
the selection procedure are: resistant
418 Gunh A. Mellström, Anders Boman

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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