IJC

International Journal of Cancer

Handling chemotherapy drugs—Do medical gloves really

protect?
Lilla Landeck1, Ernesto Gonzalez2 and Olaf Manfred Koch3
1
Department of Dermatology, Ernst von Bergmann General Hospital, Potsdam, Germany
2
Department of Dermatology, Massachusetts General Hospital, Harvard Medical School, Boston, MA
3
Department of Oncology, Klinikum Osnabru€ck, Osnabru
€ck, Germany
Mini Review

Due to their potential mutagenic, carcinogenic and teratogenic effects occupational exposure to chemotherapy drugs should
be kept to a minimum. Utilization of personnel protective devices, especially the use of protective medical gloves, is a main-
stay to avoid skin contact. The choice of appropriate gloves is of outstanding importance. For optimal protection in the oncol-
ogy setting it is essential to establish general guidelines evaluating appropriate materials and defining quality standards.
Establishing these guidelines can facilitate better handling and avoid potential hazards and late sequelae. In Europe there are
no specific requirements or test methodologies for medical gloves used in the oncology environment. The implementation of
uniform standards for gloves used while handling chemotherapy drugs would be desirable. In contrast, in the US medical
gloves used to handle chemotherapy drugs have to fulfill requirements according to the ASTM International (American Society
of Testing and Materials) standard D 6978-05. Nitrile or natural rubber latex is a preferred basic glove material, while vinyl is
considered inappropriate because of its generally increased permeability. For extended exposure to chemotherapy drugs, dou-
ble gloving, the use of thicker gloves and the frequent change of gloves increases their protective power.

Introduction ampoules, exposure due to leakage in venous port and intra-

According to the International Agency for Research on Can-
cer (IARC) of the World Health Organization, there were
14.1 million new cancer cases, and 32.6 million people living
with cancer (within 5 years of diagnosis) in 2012 worldwide.
Cancer rates will further increase in the near future.1 This is
related to increased longevity since the majority of cancers
occur in the older population. Tobacco smoking and new
food habits will lead to increasing incidences of lung and gas-
trointestinal cancers in many parts of the world.2
As chemotherapy agents remain the mainstay in the medi-
cal treatment of cancer, exposure to those drugs in the occu-
pational setting will be of growing concern. Employees at risk
are those who are involved in the manufacture, preparation,
handling and administration of these drugs. This includes
pharmacy technicians, chemists, transport services, cleaning
staff, nurses, oncologists, and surgeons using drugs in the
operation theatre. Routes of exposure to health care profes-
sionals include contact with contaminated vials and
Key words: chemotherapy drugs, speciality patient examination
gloves, prevention in health care workers, basic glove materials: latex,
nitrile, vinyl
DOI: 10.1002/ijc.29058
History: Received 9 Dec 2013; Accepted 13 Jun 2014; Online 30 Jun
2014
Correspondence to: Lilla Landeck, Department of Dermatology,
Ernst von Bergmann General Hospital, D-14467 Potsdam, Charlot-
tenstr. 67, Germany, Tel.: 149-331-2415502, Fax: 149-331-2415500,
E-mail: llandeck@klinikumevb.de
venous administration systems, and aerosols which are
released during preparation and administration.3,4 The excre-
tions of patients such as urine, feces, vomit, and sweat may
be contaminated with chemotherapy drugs leading to sub-
stantial amounts of them in urine bags, clothes and bed-
ding.3,4 In 2005, the 10 most commonly prescribed
chemotherapy drugs among 111 pharmacies in Germany
included fluorouracil (n per pharmacy 1935), cyclophospha-
mide (n 5 639), etoposide (n 5 479), cisplatin (n 5 454),
gemcitabine (n 5 446), carboplatin (n 5 328), cytarabin
(n 5 315), irinotecan (n 5 309), oxaliplatin (n 5 306), and
doxyrubicin (n 5 303).5
At present, more than 100 anticancer drugs are used in
daily clinical practice.6,7 Depending on their mode of action,
chemotherapy drugs can be subgrouped into alkylating
agents, vinca alkaloids, anthracyclines, antimetabolites, aro-
matase inhibitors, and topoisomerase inhibitors.8 They
inhibit the proliferation of cells and due to their generally
non-selective mode of action, healthy cells may also be dam-
aged resulting in adverse and toxic effects.4,9 Toxic effects
may be acute (e.g. vomiting, nausea) or delayed. Among
delayed toxic effects mutagenic, carcinogenic and teratogenic
effects are the most hazardous.4 Mutagenic effects have been
observed in mammalian systems in both in-vitro and in-vivo
for many chemotherapy drugs.10 Similarly, teratogenic effects
have been found for several chemotherapy drugs.11–14 In
some epidemiologic studies, it has been observed that nurses
handling chemotherapy drugs during pregnancy had an
increased number of miscarriages, malformations, and low

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Landeck et al.
birth weights or preterm deliveries.15 In addition, an associa-
tion between menstrual dysfunction and exposure to chemo-
therapy drugs has been reported.16
The appearance of toxic effects is considered acceptable in
patients because of the therapeutic benefits. The occurrence
of primary tumors among healthy subjects such as healthcare
professionals is not acceptable.17,18 It is unlikely there is a
threshold for the level of exposure health care professionals
can experience and still be free of any adverse effects.4 Health
care professionals handling chemotherapy drugs should keep
exposure to a minimum. Since absolute avoidance of chemo-
therapy drugs is not feasible, there is a high demand for utili-
zation of personal protective measures in conjunction with
the implementation of generally accepted guidelines. As the
cumulative exposure of chemotherapy drugs in health care
professionals may lead to delayed long-term toxic effects
even after years or decades of exposure, it is important to
emphasize the implementation of appropriate protective
measures in the working environment.
Herein we provide an overview of the specific characteris-
tics, advantages and pitfalls of protective gloves commonly
used for handling chemotherapy drugs in a clinical situation
and reviewed the current standards used by the American
Society of Testing and Materials (ASTM International) and
the European Standards (EN) for medical gloves used in the
oncology settings.
Glove Materials
In oncology and haematology, gloves are a prevention mainstay
for health care professionals. Medical gloves are used to protect
patients and medical staff from the cross-contamination of
microorganisms and chemicals by providing a barrier to infec-
tious materials and other contaminants. When choosing appro-
priate gloves the integrity of the barrier is a key consideration.
This is strongly related to the raw materials used to make the
gloves. As shown in Table 1, the three most frequently used
raw materials for gloves used in the medical environment are
natural rubber latex (NRL), nitrile (acrylonitrile-butadiene) and
vinyl or polyvinyl chloride (PVC).19 Less frequently used glove
materials include neoprene (synthetic rubber), polyvinyl alcohol
(PVA), and polyethylene (PE).19
In medical environments, natural rubber latex gloves are
most common because of their excellent fit and handling
characteristics, particularly related to their tactile sensitivity.
Rubber latex is extracted from rubber trees, such as Hevea
braziliensis. Latex is a sticky, milky colloid drawn off by
making incisions into the bark. Later the latex is refined into
rubber by a vulcanization (boiling) process that utilizes
chemical additives such as accelerators, anti-oxidants, etc.
The establishment of universal precautions to prevent
HIV contamination in the 1980s and 1990s increased rates of
both, allergic contact dermatitis as well as immediate hyper-
sensitivity to latex proteins. Particularly latex contact urticaria
was reported. It was largely attributed to the powdering of
gloves.20,21 Factors that also contributed to this increase were
Int. J. Cancer: 137, 1800–1805 (2015) V
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1801
the heightened number of health care providers, including
dentists, required to wear powdered gloves as well as the
changes introduced in manufacturing gloves to cope with the
increased demand. When taking off gloves powder soaked
with latex proteins can be dispersed in the air and induce
immediate allergic sensitization. Remedial actions have been
introduced by regulatory agencies that include the elimina-
tion of additives to rubber that cause allergic contact derma-
titis as well as eliminating the powder to prevent diffusion of
the latex particles in the air. These interventions, primarily in
the hospital environment, have markedly reduced both
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adverse reactions to rubber and latex.22–24
Furthermore, replacement of natural latex rubber gloves
by synthetic rubber gloves, such as nitrile and vinyl has a sig-
nificant impact in reducing allergic reactions to latex-
containing rubber gloves. Nitrile gloves are made from
acrylonitrile-butadiene and contain no latex protein. Thus
they are ideal for latex-sensitive subjects. However, they are
not as flexible as latex and may cause type IV allergic reac-
tion resulting in allergic contact dermatitis against the rubber
additives (e.g. thiurams, dithiocarbamates, mercaptobenzo-
thiazoles) that are necessary in their production.25,26
Although vinyl gloves typically do not contain rubber addi-
tives27 and could theoretically serve as an alternative for type
IV rubber accelerator allergic individuals, they have been
found to be inferior in both durability and permeability and
therefore less protective to microorganisms and chemother-
apy drugs compared to other glove materials (latex,
nitrile).28–30 Vinyl gloves contain phthalates, a plasticizer
used in the manufacturing process of these gloves. Phthalates
have been associated with impaired reproduction and human
development as well as with breast cancer and lymphomas.31
A study on the permeability of 13 different gloves to 13
chemotherapy agents revealed vinyl gloves being the most
permeable, even after short term application.30
Legal Requirements and Test Methodologies for
Medical Gloves
Medical gloves are legally covered by the European Council
Directive 93/42/EEC and the European Standard (EN)
455.32–34 EN 455 defines the minimum protective properties;
it specifies requirements for shelf life, labeling and disclosure
of information relevant to the test method used. In contrast
to the high demand of medical gloves, regulations for quality
testing of those are designed rather to test physical properties
(e.g. dimension, strengths) and macroscopic material defects
due to the water leak test than to investigate the safety with
regard to permeation of microorganisms or chemicals.34
European standards for medical gloves according to EN 455
do not require permeability tests for microorganisms or for
chemicals. Medical gloves do not confer uniform protection
against the medical environment.
The EN 374 defines performance characteristics of gloves
with regard to protection against chemicals and/or microor-
ganisms (chemical protection gloves). The individual
 1802 Handling chemotherapy drugs—Do gloves really protect?

Table 1. Strengths and limitations of commonly used glove materials latex, nitrile and vinyl

Natural rubber latex (NRL) Synthetic rubber nitrile Vinyl, polyvinylchloride (PVC)
Strengths
Durability  Benchmark for durability  Good durability  Inferior when compared
and dexterity to latex and nitrile
Resistance  Good resistance to many chemicals  Good resistance to many  Resistant to oils and ozone
(mild acids, alcohols, chemicals, e.g. oils
bases, most dilutions of chemicals)
 Highly resistant to punctures  Alternative for latex
allergic individuals
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 Visibly rip when punctured

Limitations
Not recommendable  Oils, ether, organic dilations  Ketones and organic solvents  Not recommendable for use with
for use in chemotherapy drugs or alcohol
 Not as flexible as NRL  Less protective to permeation of
microorganisms and chemicals
 Limited durability, elasticity
Increased potential for
punctures and tears
Further side effects  Type I allergic reactions may occur in  Type IV allergic reactions  Contain phthalates; possible
some subjects, particularly against vulcanization carcinogenic effects
when gloves powdered accelerators may occur
Deterioration  Ozone, oxygen and ultraviolet  Ozone, oxygen and
(UV)-light can deteriorate UV-light can deteriorate

protection level of gloves is higher when they are certified
according to each regulation, EN 455 and 374.34,35 Gloves
tested for the US market have to meet criteria defined by the
American Society of Testing and Materials (ASTM
International).
Standard test methodology for protective glove barrier and
resultant glove characteristics
Standard test methods of the protective glove barrier include
the investigation of the (i) glove penetration and (ii) permea-
tion. Standard tests for penetration and permeation are speci-
fied in EN 374 (European manufacturers) and similarly in
ASTM F739, F1383, ASTM F903 (US manufacturers).35–38
Penetration refers to the passage of chemicals through macro-
scopic holes or pores and is tested by an air or water leakage
test. In this test, gloves are filled with 1,000 ml water and visually
checked for macroscopic holes and leaks for 2 min. This test
determines acceptance quality level (AQL) values.35 The AQL
value names the maximum share of defective units in a batch
that can be considered as satisfactory quality for purposes of a
sampling inspection. For medical/surgical gloves, an AQL of 1.5
is required, which means that of 100 tested gloves less than 2
have a defect.35 Further performance classes are as follows:
Class 1 AQL < 4.0
Class 2 AQL < 1.5
Class 3 AQL < 0.65
In addition, permeation refers to the migration of chemicals
through the protective glove material on a molecular level
(sorption, diffusion, desorption) to the skin. Permeation
increases with increasing (i) concentration and temperature of
the chemical, (ii) exposure time, and (iii) if multiple proce-
dures are conducted including rubbing and stretching of the
gloves.30 Also permeation increases with decreasing thickness
of the gloves. Key parameter for permeation measurement is
the breakthrough time in minutes.35 The breakthrough time is
defined as the elapsed time between the initial application of a
test chemical and the point of time at which a permeation rate
(PR) of 1 mg/min/cm2 (EN 374-3 Standard) respectively 0.1
mg/min/cm2 (ASTM F739 standard) is detected.35,37 There are
six performance indicators classified:
Breakthrough time
>10 min Performance class 1
>30 min Performance class 2
>60 min Performance class 3
>120 min Performance class 4
>240 min Performance class 5
>480 min Performance class 6
Gloves are regarded to be chemically resistant and corre-
spondingly labeled if gloves protect against 3 out of 12
defined chemicals (methanol, acetone, acetonitrile, dichloro-
methane, carbon disulfide, toluene, diethylamine, tetrahydro-
furan, ethylacetate, n-heptane, sodium hydroxide 40%,
sulfuric acid 96%) for at least 30 min; performance class 2.35
Only the EN 374 requires testing of chemical resistance,
while EN 455 which applies specifically to medical gloves,

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Table 2. Pictograms labeled on boxes of medical gloves tested according to EN 374

Pictogram for microbiological resistance: This pic-
togram on gloves indicates the level of penetra-
tion in terms of the Acceptance Quality Level
(AQL). Gloves labeled with this pictogram display
an AQL of at least 1.5
Pictogram for chemical resistant
gloves: Gloves labeled with this
sign are firm to at least 3 of the
defined 121 test chemicals for at
least 30 min
Pictogram labeling gloves with marginal chemical
resistance: Gloves labeled with this sign are margin-
ally firm to chemicals or impermeable to fluids; being
thereby firm to less than 3/121 chemicals and/or
having a breakthrough time of less than 30 min

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1
Methanol, acetone, acetonitrile, dichloromethane, carbon disulfide, toluene, diethylamine, tetrahydrofuran, ethylacetate, n-heptane, sodium hydrox-
ide 40%, sulfuric acid 96%.

does not.34,35 The EN 374 describes the following pictograms
that are labeled on glove packages (Table 2).35
Degradation describes the interaction between the chemi-
cal substance and the glove material. The glove may become
brittle and split, may swell and lose its mechanical strength
or simply dissolve. As there is currently no standard in the
European Union or the United States for degradation testing,
manufacturers are free to use individual test methods, mak-
ing it difficult for the consumer to compare the obtained
results. Degradation of gloves may be influenced by interac-
tions between the chemicals and glove material. Polar glove
materials (polyvinyl alcohol, nitrile) may be degraded by
polar chemicals (e.g. acetone) and non-polar glove materials
(e.g. natural rubber latex, neoprene) are degraded by non-
polar substances (e.g. hexane, oils, benzene), therefore offer-
ing less protection. It is a well-established policy in the US to
avoid petroleum-containing products such as lubricants
which can degrade the rubber/latex39 found in gloves.
Generally polar glove materials (polyvinyl alcohol, nitrile)
may be degraded by polar chemicals (e.g. acetone) and non-
polar glove materials (e.g. natural rubber latex, neoprene) are
degraded by non-polar substances (e.g. hexane, oils, benzene),
offering therefore less protection.
Legal requirements for protective gloves when handling
chemotherapy drugs
At present, in Europe there are no special legal requirements
to define standard characteristics and test methods for medi-
cal gloves used in the oncology environment. The implemen-
tation of particular standards for gloves applied when
handling chemotherapy drugs would be desirable. Certain
glove manufacturers perform voluntarily permeability tests
for chemotherapy drugs on their gloves. Since test methods
vary, results are often not comparable and difficult to inter-
pret by the consumer.
In the US gloves used to handle chemotherapy drugs have
to fulfill requirements according to the ASTM D 6978-05
“Standard practice for assessment of resistance of medical
glove to permeation by chemotherapy drugs” which was
introduced in 2006.40 This standard includes nine defined
chemotherapy drugs as test chemicals. Gloves are tested
against permeation of seven mandatory chemotherapy drugs
(carmustine, cyclophosphoshamide, doxyrubicin, etoposide,
5-fluorouracil, paclitaxel, thiotepa) and two additional drugs
from a list of 17 as shown in Table 3. ASTM D 6978-05 uses
ASTM F739 as test method, but with a chemical permeation
which is ten times more stringent than that is required by
ASTM F739.37,40 Compared to the European counterpart EN
374-3 it is even 100 times more rigorous (Table 3).35
Pitfalls of test methods
The presented tests implicate different problems, (i) the EN
and US standards only determine permeation under conditions
of close contact but without stretching, flexing or other factors
that will occur in a real working environment, (ii) EN tests are
conducted at a temperature of 23 6 1 C (EN 374-3), whereas
the temperature of gloved hands may easily reach >35 C, (iii)
Permeation breakthrough time is measured only for individual
chemicals, whereas real working environments are character-
ised by a mixture of different chemicals, and (iv) as a relative
weakness, the US standard ASTM D 6978-05 uses a shorter
test time of only 240 min compared to 480 min within the EN
standard.35,40 As tests are conducted according to laboratory
standards rather than to real working conditions, quality
results may not be applicable for several work settings. The
permeation rates measured in the different tests may be under-
estimated, and additional preventive measures should be taken.
Additional preventive measures: Use of thicker gloves and
double gloving
Protective glove effects depend on the thickness of the glove
material. Thicker gloves increase the breakthrough time and
offer a higher level of protection.41,42 In the surgical environ-
ment it was shown that double gloving (wearing two pairs of
gloves) or using a glove liner between the two pairs of gloves
reduced breaks in the gloves significantly.43 Extra thick gloves
seem to be as good as two pairs worn simultaneously.44 In
dynamic permeation tests for chemotherapy drugs, the highest
resistance to the tested chemotherapy drugs was observed in
natural rubber latex gloves with a thickness of at least 0.24
mm and for nitrile gloves of at least 0.16 mm thick.30
Unfortunately, the increased thickness of the glove may have

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 1804 Handling chemotherapy drugs—Do gloves really protect?

Table 3. Key differences between US and European standard test methods against chemotherapy drugs
US ASTM D 6978-05 EU EN 374-03

Test temperature 35 6 2 C 23 6 1 C
2
Permeation limit 0.01 mg/min/cm 1.00 mg/min/cm2
Part of the glove used to testing Must use thinnest part of gloves Palm of the gloves
Test chemicals Seven1 mandatory chemotherapy drugs and A minimum of three chemicals from a prede-
2 further cytostatic drugs have to be chosen fined list of 123 are used, none is a chemo-
from a predefined list of 172 therapy drug
Test time 240 min 480 min
1
Carmustine, cyclophosphoshamide, doxyrubicin, etoposide, 5-fluorouracil, paclitaxel, thiotepa.
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2
Bleomycin, carboplatin, cisplatin, cytarabine, dacarbazine, daunorubicin, docetaxel, gemcitabine, idarubicin, ifosphamide, irinotecan, mechloreth-
amine, melphalan, methotrexate, mitomycin, mitoxantrone, vincristine.
3
Methanol, acetone, acetonitrile, dichloromethane, carbon disulfide, toluene, diethylamine, tetrahydrofuran, ethylacetate, n-heptane, sodium hydrox-
ide 40%, sulfuric acid 96%.

Table 4. Failure prevention for the utilization of protective gloves
when handling chemotherapy drugs
(i) Select suitable glove material (natural rubber latex, nitrile)
with appropriate thickness (latex at least 0.24 mm, nitrile
0.16 mm). Use powder free gloves.
(ii) Gloves should meet the EN norms (EN 374 and 455) in
Europe and the ASTM (ASTM D 6978-05) standards in the
US. Test standard should be labeled on the box.
(iii) Perform preventive gloves changes every 15-20 minutes or
if torn or punctured.
(iv) Consider double gloving.
(v) Since ultraviolet radiation, high temperature and ozone
may degrade glove materials store them at a cool, dry
place away from direct sunlight. Check the expiration date
of the gloves on the box.
an effect on the dexterity and flexibility of the user when per-
forming certain tasks.
Time of exposure
Several studies on protective gloves in various medical envi-
ronments including surgery, emergency departments, trauma-
tology, gynaecology and oncology indicated an increasing
rate of glove perforations over time.30,45–47 Hansen et al.
showed that leak rates in worn gloves were higher when used
for 20 min or when used for 4 procedures in the emer-
gency department.46 Wallemacq et al. showed on permeabil-
ity testing of 13 different gloves to 13 chemotherapy agents
that all gloves materials displayed a general trend toward
greater permeation over time, increasing by a mean of five-
fold factor between 15 and 60 min.30 To avoid unnecessary
exposure to chemotherapy drugs a regular glove change is
recommended every 15 to 20 min. Further suggestions for
the utilization of protective gloves when handling chemother-
apy drugs are summarized in Table 4.
Recommendations
Because of their mode of action exposure to chemotherapy
drugs should be limited to a minimum in occupationally
exposed staff. This can be achieved by the implementation of
handling guidelines and the utilization of personnel protec-
tive measures, e.g. use of protective gloves. The choice of
appropriate gloves in the occupational setting is crucial. In
Europe, gloves used in this special environment should at
least meet quality criteria according to the European Stand-
ard EN 374 (for chemical protection gloves) and EN 455
(medical gloves). For the US market, gloves should be tested
according to the ASTM D 6978-05, which is presently the
more stringent test method for protective gloves used against
chemotherapy drugs. For procedures that expose health care
professionals to chemotherapy drugs for a longer period,
double gloving, use of thicker gloves and regular glove
changes should be considered. Glove material should be cho-
sen according to the chemical characteristics of the drugs to
be used, i.e. polarity, for maximum protection. For the
majority of chemotherapy drugs, nitrile and natural rubber
latex glove materials are preferable, while vinyl is inappropri-
ate due to its generally increased permeability. Additional uti-
lization of petroleum-based lubricants, detergents and
disinfectants are non-advisable as they may destroy the integ-
rity of the glove material, thereby producing (invisible) holes
and reducing protective characteristics.
Conclusions
To date, there are no universal standards to test gloves used
in the handling of chemotherapy drugs. As guidelines and
standard operation procedures are commonly used in oncol-
ogy, it is essential to establish general guidelines evaluating
and defining appropriate material and quality standards of
gloves. Establishing these guidelines can create the optimal
handling of chemotherapy drugs and avoid potential hazards
and late sequelae.
For the consumer, comprehensible and easy to understand
labeling about the protective properties of the gloves on the
glove box is required. Rather than to label only EN and
ASTM standard numbers and pictograms, the exact names of
the drugs accompanied by the intended time of protection
should be visible on the box.

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