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MAIN FEATURE
Gloves as PPE: Standards for
permeation and penetration
Derek Watts
Introduction
atex, polychloroprene, nitrile
L and vinyl thin film single use
gloves are used by the million
in cleanrooms around the world
every day. These gloves are worn
for one of two reasons; either to
protect products from
contamination or to protect the
wearer from harm caused by
exposure to chemicals. This article
looks at protecting the wearer and
tries to unravel some of the
technicalities that should be
considered when specifying
gloves.
Protective gloves work by
forming a physical barrier between
the wearer and the chemicals that
they are handling and will remain
effective until the barrier is
breached. Many users are lulled
into a false sense of security
because they are given protective
gloves to wear. They believe that
they can don them at the
beginning of their shift and that
they will remain protected
throughout their work time. How
wrong they are. There is a
possibility that, during the course
of their shift, the barrier will be
breached via one of two
mechanisms; permeation or
penetration.
The definitions of permeation
and penetration are provided by
the European Standards covering
gloves used for personal
protection, but before we look at
permeation and penetration in
detail let us consider the
background and purpose of
standards.
Standards
Standards are technical documents
intended to be used to define state
of the art specifications,
definitions, methodologies and
guidelines.
16 Clean Air and Containment Review • Issue 2 • April 2010
Standards are created by
bringing together interested
parties such as manufacturers,
consumers and regulators of a
particular material, product,
process or service. The resultant
committees draw inputs from as
many sources as possible to
develop practical standards that
can be adopted by manufacturers
and service providers as minimum
specification requirements. All
parties benefit from standardis-
ation through increased product
safety and quality.
Unless required by regulation,
the application of standards is
voluntary and companies may use
them to demonstrate that their
products, services or systems have
been assessed by an independent
body, achieving at least the
minimum performance levels
required. Compliance with
standards helps customers to
specify their purchased products
with the confidence that they are
buying a quality product which
will meet their requirements.
Because published standards play
such a large part in unifying
product designs (particularly in
specifying minimum safety
requirements) they are often used
as a means of meeting safety
related regulations. In this context
the example that springs readily to
mind are the various European CE
Marking Directives. Each directive
has an associated list of standards,
compliance with which is deemed
to satisfy specific parts of the
regulation. All standards that are
associated with European
Directives have been harmonised
for use throughout Europe and are
recognisable by the prefix EN to
the standard’s number.
EN standards (or Euro Norms)
are created through the European
committee for Standardization
(CEN). CEN is a non-profit
organization set up under Belgian
law. Once approved and issued, an
EN automatically becomes a
national standard in the 31
member countries.
Gloves for protection against
chemicals are classed as Personal
Protective Equipment (PPE) and
are regulated by the
implementation of the European
PPE directive, 89/686/EEC. The
harmonised standard covering
gloves used as PPE against
chemicals is EN 374: 2003. The
standard is broken down into 3
parts:
1. EN 374-1: 2003 Protective gloves
against chemicals and micro-
organisms – Part 1: Terminology
and performance requirements
2. EN 374-2: 2003 Protective gloves
against chemicals and micro-
organisms – Part 2:
Determination of resistance to
penetration
3. EN 374-3: 2003 Protective gloves
against chemicals and micro-
organisms – Part 3:
Determination of resistance to
permeation by chemicals
Permeation
EN 374-3: 2003 Defines permeation
as follows:
Permeation is the process by
which a chemical moves through a
protective glove material on a
molecular level. Permeation
involves the following:
• Absorption of molecules of the
chemical into the contacted
(outside) surface of a material
Figure 1: Diagram showing the permeation of
chemical molecules through a barrier
Clean Air 2:Layout 1 19/4/10 13:19
Figure 2. Graph showing the rapid increase of permeation rate once breakthrough has occurred.
Figure 3. Diagram showing the apparatus for air leak test taken from EN 374.
• Diffusion of the absorbed
molecules in the material
• Desorption of the molecules
from the opposite (inside)
surface of the material
Put more simply, chemical
permeation can be considered as
the passage of a chemical through
a barrier layer at a molecular level.
Molecules of the chemical are
absorbed by the barrier material
and as the number of molecules
absorbed increases, the chemical
gradually works its way through
the material and out of the other
side. By way of illustration,
imagine a layer of dry sponge that
has a trickle of water poured upon
it. At first the water sits on the
surface of the sponge. It then starts
to soak in (absorption) and as it
does so it spreads out throughout
the sponge (diffusion). As more
water is poured on, the sponge
‘fills up’ until the volume held
Page 17
Key
1. Circular fixing mandrel
2. Non return valve
3. Water supply
4. Pressure gauge
5. Flexible pipes
6. Tank
7. Instrument panel
8. Compressed air supply
9. Pressure regulator
reaches the point where water
starts to trickle from the opposite
side (desorption). The trickle of
water emerging will increase in
volume until a steady rate of flow
is reached.
When assessing the suitability
of a glove for its intended use, the
performance of the material
against the permeation of
chemicals needs to be considered
along with the proposed duration
of use/exposure. The rate of
permeation through protective
gloves varies dependent upon the
glove/chemical combination. The
elapsed time between the initial
application of a test chemical to the
outside surface of a protective
glove and its subsequent presence
on the other side of the material,
when it reaches a specific flow
rate, is known as the breakthrough
time and is the parameter which is
used to determine the resistance of
the glove material to the chemical.
Clean Air and Containment Review • Issue 2 • April 2010
MAIN FEATURE
Under EN 374, breakthrough is
deemed to have occurred when the
flow rate of 1 µg/cm2/min is
reached.
Penetration
Penetration is defined in EN 374 as
the movement of a chemical
and/or micro-organism through
porous materials, seams, pinholes,
or other imperfections in a
protective glove material on a
nonmolecular level.
Another way of considering this
is where the chemical passes
through holes in the barrier. The
illustration for this mechanism is
that of a polythene bag full of
water. If the polythene is intact the
water will stay in place. If the
polythene has any holes (e.g.
pinholes) the water will penetrate
and escape.
Glove testing –
penetration
If a glove does not protect against
liquids and gas, it could be
hazardous to wearers. EN 374-2
outlines the testing standard for
penetration which involves a
water leak test and an air leak test.
Tests are performed with model
liquids (e.g. water) and gases (e.g.
nitrogen).
Air Leak Test – A glove is
immersed in water and its interior
is pressurized with air. A leak will
be detected by a stream of air
bubbles from the surface of the
glove. (Figure 3)
Figure 4. Diagram showing the apparatus for
water leak test.
17
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MAIN FEATURE
Table 1. Acceptance Quality Levels
(AQL) and inspection levels from ISO
2859.
Performance Acceptance Inspection
level quality level levels
Level 3 <0.65 G1
Level 2 <1.5 G1
Level 1 <4.0 S4
Water Leak Test – A glove is
suspended from a test frame and is
filled with a minimum of 1 litre of
water. A leak is detected by the
appearance of water droplets on
the outside of the glove. (Figure 4)
A glove which resists
penetration and passes both air
leak and water leak tests to
Performance Level 2 is deemed to
be an effective barrier to micro-
biological hazards (however the
standard stresses that this test does
not guarantee protection against
viruses). The air leak test may not
be appropriate for all types of
glove. For example, parts of some
gloves might over inflate, while
other parts of the same glove are
only partially inflated or not
entirely filled with air. If the air
leak test proves to be
inappropriate, only the water leak
test need be performed to
determine penetration.
Table 2. List of predefined test chemicals in BS EN 374.
Predefined chemical in EN 374
Methanol
Acetone
Acetonitrile
Dichloromethane
Carbon disulphide
Toluene
Diethylamine
Tetrehydrofurane
Ethyl acetate
n-Heptane
Sodium hydroxide 40%
Sulphuric acid 96%
* Chemical Abstracts Services registration number. A division of the American Chemical Society.
18 Clean Air and Containment Review • Issue 2 • April 2010
Page 18
Figure 5. Permeation test cell.
The performance levels are
ascertained from the Acceptance
Quality Level (AQL) set in
manufacturing and are defined in
EN 374 as shown in Table 1.
Gloves from each single lot or
batch are sampled according to
ISO 2859-1 and inspected. ISO 2859
is an International Standard
covering sampling procedures for
inspection by attributes. Part 1 of
the standard sets down the
sampling schemes indexed by
AQL and the inspection level for
assuring quality during
production. The performance level
is determined by the required
Inspection level and the AQL
(Table 1). The inspection level
determines the sample size based
on the manufacturing batch size
Class
Primary alcohol
Ketone
Nitrile compound
Chlorinated paraffin
Sulphur containing organic compound
Aromatic hydrocarbon
Amine
Heterocyclic and ether compound
Ester
Saturated hydrocarbon
Inorganic base
Inorganic mineral acid
and is given in a lookup table in
ISO 2859-1. The AQL specifies the
number of defective gloves that are
allowed to be in the sample before
the rejection of the entire batch and
is also read from a lookup table in
ISO 2859-1. By way of example, a
manufacturer produces a batch of
500,000 and wants to claim Level 3
performance. Inspection level G1
predetermines that the
manufacturer must draw a random
sample of 500 gloves for each test
(air and water leak). AQL 0.65
means that for each test six gloves
from the 500 sample are allowed to
have pinholes, but if a seventh is
found the entire manufacturing
batch must be rejected.
Glove testing –
permeation
Permeation testing is carried out
by placing a sample taken from the
glove under test in a special test
cell so that the glove material
separates the test cell into two
chambers (Figure 5). One chamber
is filled with the challenge
chemical and the other with a
collection medium, which is a
liquid in which the challenge
chemical will dissolve. The
collection medium is tested at
regular intervals by mass
spectography to measure the
CAS* number Code letter
67-56-1 A
67-64-1 B
75-05-8 C
75-09-2 D
75-15-0 E
108-88-3 F
109-89-7 G
109-99-9 H
141-78-6 I
142-85-5 J
1310-73-2 K
7664-93-9 L
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MAIN FEATURE

Table 3. Permeation performance

levels detailed in EN 374.

Performance Measured
Level Breakthrough
Time (MBT)

Level 1 Minimum 10 minutes

Level 2 Minimum 30 minutes
Level 3 Minimum 60 minutes
Level 4 Minimum 120 minutes Gloves that pass the Gloves that fail the Gloves that pass the
Level 5 Minimum 240 minutes permeation tests must be permeation tests but pass penetration test to at least
Level 6 Minimum 480 minutes marked with the conical the penetration tests must Level 2 are considered to
flask symbol. The letters be marked with the open be micro-organism
printed below the flask beaker symbol. The resistant and may be

amount of challenge chemical held

represent the chemicals symbol is intended to marked with the symbol

in solution. This gives a

used in testing (as per indicate low level above.

measurement of the volume of

codes shown in Table 2). protection.

challenge chemical that has passed

The “i” shown below the

through the sample material,

flask indicates that the

enabling the flow rate to be

details of the permeation

calculated and monitored.

tests are available – they

EN 374-1 states that in order to

must be on the packaging

be compliant as offering chemical

or in the Instructions for

protection, the glove under test

Use.

must be graded as offering at least
level 2 protection against at least
three chemicals selected from a list
of 12 that are published in the
standard (Table 2). The performance
levels are defined by the time taken
for the test chemical to permeate the
test sample (Table 3).
EN 374-1: 2003 also provides
guidance on how the Measured
Breakthrough Time (MBT) should
be expressed in performance levels.
A performance level of 2 is
obtained if the MBT is a minimum
of 30 minutes and performance
levels increase further the higher
the MBT. When assessing the
suitability of a glove, the
performance level(s) should be
considered. The higher the
performance level, the better the
level of protection.
Selecting the right glove
for the job
When selecting protective gloves it
is important to know what
chemical is to be protected against,
then select a glove that will offer
suitable resistance. This may take a
little detective work and a call to
the glove manufacturer. With a
pass at level 2 for only three from
Figure 6. Symbols to be used in packaging (EN 374).
the list of twelve EN 374 chemicals
required to classify a glove as
offering chemical protection, it is
highly unlikely that the chemical
in use will be listed on the glove’s
packaging.
Because EN 374 is very specific
about the chemicals to be used in
testing and qualification of
protective gloves the resultant
labelling of the packaged product
can be confusing. The standard
specifies three different symbols
that must be used on packaging
(Figure 6).
A shortcoming of EN 374 and its
labelling requirements is that some
very good protective gloves are
required to be labelled with the
open beaker symbol (indicating
low level protection) just because
the chemicals that they are
designed to protect against are not
on the prescribed list. For example,
gloves that have been designed for
use with chemotherapy drugs can
have a performance in excess of
Level 6 against a half dozen or so
very aggressive and dangerous
chemicals, but are still classed as
low level protection by the
standard. It is easy to fall into the
trap of thinking that just because
the flask symbol is missing from a
glove’s labelling it doesn’t possess
good protective properties.
Summary
When selecting or specifying
gloves for chemical protection it is
important to remember that it
really is a case of “horses for
courses”. Gloves that bear a CE
mark and EN 374 symbols are
undoubtedly good gloves. They
have been tested with chemicals
and are proven to be resistant to a
level that will protect the wearer,
BUT will they offer adequate
protection against chemicals
present in any specific work area?
The answer is, not necessarily. To
return to the example of
chemotherapy drugs, there are
many CE marked protective gloves
that will give excellent protection
against acids but that will allow
chemotherapy drugs to permeate
them in a matter of seconds.
Conversely, gloves that give great
protection against chemotherapy
drugs may not give adequate
protection against, say, an acid.

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MAIN FEATURE

The onus is on employers to

provide the correct and
Derek Watts worked on the original Channel

appropriate level of Personal

Tunnel project, having graduated in 1974 with a

Protective Equipment to their staff.

BSc in Mining Engineering from Imperial College.

It is therefore important to
In 1975 Derek joined Philip Brothers (Phibro), the

understand not only the difference

commodities trading division of Investment

between penetration and

Bankers Salomon Brothers, which operated 42

permeation but also the symbols to

offices worldwide. He remained with the

look out for when assessing gloves

company for nearly 15 years, working in London,

for their suitability and the

New York and Bangkok before settling in Kuala

meaning of those symbols. It is

Lumpur and becoming the company’s youngest

also important to match the glove

ever Managing Director. In late 1988, correctly

to the application and to put

forecasting the surge in demand for examination
gloves, Derek constructed a gloves factory, quickly

procedures in place which ensure

moving from standard powdered exam gloves to specialise in powder-free cleanroom

that gloves are changed in a timely

gloves. He pioneered many innovations under the Bioclean brand, including the

manner. Failure to do so could

introduction of no-paper packaging of sterile cleanroom gloves for the pharmaceutical

result in a potentially severe and

industry. Having grown glove sales to over 100 million gloves per annum, Derek sold the

lasting injury to an employee and

business and moved back to the UK in 1996 where he incorporated Nitritex Ltd to import

a legal claim for damages.

and distribute the BioClean gloves. Under his leadership, the company became profitable
within 12 months and has, since then, greatly expanded its product range, opened
subsidiaries in four countries to service a global client base and achieved consistent
double-digit annual growth.
Correspondence to: Derek Watts, NITRITEX, Minton Enterprise Park, Oaks Drive,
Newmarket, Suffolk CB8 7YY, UK. Tel: +44 (0) 1638 663338; Fax: +44 (0) 1638 668890
derek@nitritex.com; www.nitritex.com

20 Clean Air and Containment Review • Issue 2 • April 2010