Hand Protection

1. EN ISO 21420:2020+A1:2024 – General Requirements for Protective Gloves

1.1 Design and construction

1.2 Comfort, fit, and dexterity

1.3 Information and labelling

1.4 Scope of gloves covered

2. Single-Use Gloves: Standards Overview

2.1 Single-Use Gloves

2.2 Overview of applicable EN standards

3. Chemical Protective Gloves – EN ISO 374 Series

3.1 EN ISO 374-1 – Chemical resistance classification

3.2 Type A, Type B, Type C explained

3.3 Chemical code letters and pictograms

3.4 EN ISO 374-2 – Penetration testing

3.5 EN ISO 374-4 – Chemical degradation

3.6 EN ISO 374-5 – Biological risks (contextual / limited relevance)

3.7 EN 16523-1 – Chemical permeation test method

4. AQL & Glove Quality Testing

4.1 What Is AQL in Glove Quality Testing?

4.2 AQL Standards

4.3 Practical Meaning of AQL Levels

4.4 What is Sampling?

4.5 How Sampling Sizes Are Determined in Medical Glove Manufacturing (EN 455-1)

4.6 MD vs. PPE Glove Sampling: What’s the Difference?

5. Mechanical Protection – EN 388

5.1 Mechanical hazards covered

5.2 Performance ratings explained

5.3 Changes introduced in EN 388:2016

5.4 Circular blade vs ISO 13997 cut testing

5.5 Impact protection marking (“P”)

6. Electrostatic & ESD Protection

6.1 What is electrostatic discharge (ESD)?

6.2 Why ESD matters in industry and cleanrooms

6.3 EN 16350 – ESD requirements for gloves

6.4 ESD glove material behaviour

7. Cleanroom & Laboratory Glove Requirements

7.1 ISO 14644 cleanroom classification

7.2 ISO-based vs GMP cleanrooms

7.3 Cleanroom glove expectations

7.4 IEST-RP-CC005.4 testing and selection guidance

7.5 Particle, extractables, and residue control

8. Supported vs Unsupported Gloves

8.1 What are supported gloves?

8.2 What are unsupported gloves?

8.3 Comparison table

8.4 Typical applications by environment

9. Specialist Applications

9.1 Radioactive contamination protection

9.2 Ionising radiation gloves

9.3 When EN 421 is applicable

Protective gloves are a fundamental form of personal protective equipment used to reduce risks associated with chemical exposure, mechanical injury, electrostatic discharge, and contamination. In industrial, laboratory, and cleanroom environments, gloves are often required to meet more than one standard, as each standard typically addresses a single hazard type.

Understanding glove standards is essential for selecting suitable hand protection, ensuring regulatory compliance, and confirming that gloves perform as expected in their intended application.

What Is the Difference Between Regulations and Standards? 

Difference Between Regulations and Standards

1. EN ISO 21420:2020+A1:2024 – General Requirements for Protective Gloves

EN ISO 21420:2020+A1:2024 defines the general requirements applicable to protective gloves. It establishes baseline criteria that gloves must meet before any hazard-specific performance standards are applied. This standard focuses on usability, safety, and clarity of information rather than protection against individual risks.

1.1 Design and Construction

EN ISO 21420 specifies requirements for the physical characteristics of protective gloves. This includes considerations such as the materials used in glove construction, overall durability, flexibility, and the ability of the glove to perform its intended function without premature failure.

The design must ensure that the glove provides appropriate coverage of the hand and maintains structural integrity during use. These requirements apply regardless of whether the glove is intended for chemical, mechanical, thermal, electrical, or other general risks.

1.2 Comfort, Fit, and Dexterity

The standard includes guidance to ensure that gloves are comfortable to wear and properly fitted to the hand. Gloves must not unnecessarily restrict movement or impair the wearer’s ability to perform tasks safely and effectively.

Fit and dexterity are important factors, as poorly fitting gloves can reduce grip, increase fatigue, or introduce secondary risks during use. EN ISO 21420 therefore considers ergonomics alongside protective function to support safe, practical use in the workplace.

1.3 Information and Labelling

EN ISO 21420 defines the information that must be supplied with protective gloves. This includes details on the intended use of the glove, protection levels, limitations of performance, and any relevant maintenance or storage instructions.

Clear and accurate labelling ensures that users understand the glove’s capabilities and limitations and can select the correct glove for the task. This information forms part of the overall conformity requirements for PPE gloves.

1.4 Scope of gloves covered

The general requirements of EN ISO 21420 apply to a wide range of protective gloves designed to reduce risks to the hands in different working environments. This includes gloves intended to protect against mechanical, chemical, thermal, electrical, and other workplace hazards. The standard focuses on general safety, usability, and information requirements, and is applied in combination with hazard-specific standards depending on the glove’s intended use.

2. Single-Use Gloves: Standards Overview

2.1 Single-Use Gloves

Single-use gloves may be subject to different standards depending on their intended use and regulatory classification. Medical single-use gloves are commonly assessed against the EN 455 series, which covers aspects such as freedom from holes, physical properties, biological evaluation, and shelf life. Gloves intended to provide protection against chemical or micro-organism hazards may also be assessed against the EN ISO 374 series, depending on the level and type of protection claimed. In addition, Acceptable Quality Level (AQL) is used within acceptance sampling to assess batch quality, particularly for defects such as holes or leaks that may affect barrier performance.

2.2 Overview of applicable EN standards

Single-use gloves are governed by a range of EN standards, selected according to their intended use and claimed protection.

At ISO level, newer editions of certain standards (e.g. ISO 374-1:2024 and ISO 374-5:2024) have been published. However, many gloves currently on the market remain certified to earlier EN ISO editions, which are referenced throughout this guide. The following sections reflect these commonly used EN ISO designations.

These include both product standards, which define performance requirements, and test methods, which are used to evaluate specific aspects of glove performance.

• EN ISO 374-1:2016+A1:2018 – Defines chemical resistance categories (Type A, B, C) based on performance against a specified list of chemicals.
• EN ISO 374-2:2019 – Specifies the test method for determining resistance to penetration (e.g. air and water leak testing), used to assess glove integrity against chemicals and micro-organisms.
• EN 374-3:2003 – Determination of resistance to permeation by chemicals; superseded by EN 16523-1:2015
• EN ISO 374-4:2019 – Measures degradation caused by chemical exposure.
• EN ISO 374-5:2016 – Specifies requirements for protection against micro-organisms, including bacteria and fungi, with optional virus protection where additional testing is carried out.
• EN 16523-1:2015 – Specifies the test method for determining material resistance to permeation by liquid chemicals under conditions of continuous contact.
• EN ISO 16604:2004+A1:2009 – Specifies the test method for assessing resistance of protective clothing materials (including gloves) to penetration by blood-borne pathogens (e.g. viruses), typically used to support virus protection claims.
• EN 455 series – Specifies requirements for medical single-use gloves, including freedom from holes, physical properties, biological evaluation, shelf life, and extractable chemical residues, depending on the part of the series applied. This standard applies to gloves placed on the market as medical devices.

The correct application of these standards depends on the glove’s regulatory classification and intended use, making it essential to identify whether a single-use glove is acting as PPE, a medical device, or both before assessing performance claims.

3. Chemical Protective Gloves – EN ISO 374 Series

3.1 EN ISO 374-1 – Chemical resistance classification

EN ISO 374-1 defines the performance requirements and classification system for protective gloves against hazardous chemicals. It classifies gloves according to their chemical permeation performance against specified test chemicals and forms the basis for the Type A, Type B, and Type C designations used on glove markings. This helps users identify gloves that are suitable for different levels of chemical exposure.

3.2 Type A, Type B, Type C explained

These classifications ensure that gloves are selected according to the level and range of chemical exposure in the working environment. A higher classification indicates protection against a greater number of chemicals.

Type A (High chemical resistance)

Provides at least 30 minutes of breakthrough protection (performance level 2) against at least 6 chemicals from the standard list.

Type B (Moderate chemical resistance)

Provides at least 30 minutes of breakthrough protection against at least 3 chemicals from the same list.

Type C (Basic chemical resistance)

Provides at least 10 minutes of breakthrough protection (performance level 1) against at least 1 chemical from the list.

The specific chemicals for which protection has been achieved are indicated by letter codes displayed beneath the EN ISO 374 pictogram.

Each letter corresponds to a defined test chemical from the standard list. For example:

Type A gloves will display at least 6 letters

Type B gloves will display at least 3 letters

Type C gloves will display at least 1 letter

In the pictograms shown, the “X” symbols are placeholders representing these chemical code letters. On certified gloves, these will be replaced with the actual letters corresponding to the chemicals tested.

3.3 Chemical code letters and pictograms

See all 18 test chemicals on the table below:

3.4 EN ISO 374-2 – Penetration testing

EN ISO 374-2:2019 specifies the test method used to assess the resistance of protective gloves to penetration by liquids and micro-organisms. The standard evaluates glove integrity using leak testing methods, such as air or water tests, to determine whether defects such as pinholes are present. This testing confirms whether the glove forms an effective barrier, but does not measure resistance to chemical permeation or degradation.

3.5 EN ISO 374-4 – Chemical degradation

EN ISO 374-4:2019 is a standard that specifies the method for determining the degradation of protective gloves when exposed to chemicals. This standard assesses changes in glove material properties, such as strength and flexibility, following chemical exposure. The degradation testing helps to evaluate whether the glove material retains its protective qualities or becomes weakened after chemical contact. This standard is crucial for ensuring that gloves maintain their integrity and continue to provide reliable protection in environments where workers handle hazardous substances.

3.6 EN ISO 374-5 – Biological risks (contextual / limited relevance)

EN ISO 374-5:2016 specifies requirements for protective gloves against micro-organisms, including bacteria and fungi. Gloves that meet these requirements display the biohazard pictogram. Where additional testing has been carried out to assess resistance to viral penetration (typically using ISO 16604), the marking “VIRUS” is shown beneath the pictogram. This indicates that the glove has been tested for resistance to viruses under controlled conditions.

3.7 EN 16523-1 – Chemical permeation test method

EN 16523-1:2015 is a standard that specifies the method for determining the resistance of protective gloves to the permeation of chemicals. This standard focuses on testing how well gloves prevent the passage of hazardous chemicals through the material, simulating real-life conditions where gloves might be exposed to harmful substances. The standard helps to assess the permeation time and rate of penetration for various chemicals, ensuring that gloves provide effective protection in environments where workers are at risk of chemical exposure.

4. AQL & Glove Quality Testing

4.1 What Is AQL in Glove Quality Testing?

Acceptable Quality Level, or AQL, is a statistical measure used to determine the maximum number of defective gloves permitted in a production batch based on specific quality tests, such as the water or air penetration test to detect microporous holes. These tests are crucial to confirm that gloves offer the necessary protection against contaminants and hazards, including pinholes, tears, or other weak points that could compromise hand safety. 

Essentially, it reflects the glove’s overall quality — particularly its ability to provide an effective barrier against contaminants. A lower AQL means fewer defects in the batch, translating to higher protection for users. 

4.2 AQL Standards

EN 455-1 – Medical Gloves

EN 455-1 is a standard specifically designed for medical gloves used in healthcare settings, including examination and surgical procedures. The primary focus of this standard is ensuring gloves offer reliable protection from contamination, safeguarding both healthcare providers and patients.

The testing method under EN 455-1 is exclusively the water penetration test. During this test, each glove is filled with water and carefully examined for any leaks. Gloves intended for examination purposes typically must meet an AQL of 1.5 or lower, whereas surgical gloves must achieve an even stricter standard with an AQL of 0.65 or lower.

EN ISO 374-2:2019 – PPE Gloves

EN ISO 374-2:2019 applies to gloves classified as Personal Protective Equipment (PPE). These gloves are specifically designed for environments requiring protection from hazardous chemicals or micro-organisms.

Unlike EN 455-1, the EN ISO 374-2 standard allows either an air leak test or a water penetration test, depending on the glove material and manufacturer's preference. The air leak test involves pressurising the glove with air and immersing it in water to check for bubbles indicating leaks. Alternatively, the water penetration test, similar to the EN 455-1 test, involves filling gloves with water to detect leaks.

PPE gloves under EN ISO 374-2:2019 are graded by their performance against penetration, based on AQL levels:

• Level 3: AQL < 0.65 (highest protection against leaks)
• Level 2: AQL < 1.5
• Level 1: AQL < 4.0 (lowest protection level)

These levels indicate the glove’s barrier performance against air and liquid leaks.

4.3 Practical Meaning of AQL Levels

Different AQL levels have practical implications for glove selection. Lower AQL values such as 0.25 to 0.65 are generally preferred for higher-risk applications, such as surgical procedures or handling dangerous chemicals, due to their minimal defect allowance. Gloves with an AQL of 1.5 are suitable for general medical or industrial tasks, whereas gloves with an AQL of 4.0 should only be used for low-risk applications where minor defects are acceptable.

AQL testing is carried out before gloves are released for distribution, making it a critical part of batch release quality control. If the tested sample exceeds the maximum number of allowable defects, the entire batch is either rejected or retested under stricter criteria.

4.4 What is Sampling?

Sampling is the process of selecting a representative number of gloves from a production batch to assess the quality and safety of the entire batch. Rather than testing every glove produced, manufacturers test a specific number of gloves according to internationally recognised standards. This method ensures a practical yet statistically reliable way to evaluate if the gloves meet acceptable quality levels (AQL) for defects such as pinholes or tears. The results from the sampled gloves are used to determine whether the entire batch should be accepted or rejected based on the number of defects found.

Glove Sampling Plans Explained: How Are Sample Sizes Chosen? (EN 374-2)

The number of gloves to be tested from each batch is determined by the batch size and the inspection level selected. ISO 2859-1:1999 is the most commonly used standard for establishing sampling procedures in glove manufacturing, covering both medical and PPE gloves. Disposable gloves such as those made from nitrile, neoprene, or latex often involve large batch sizes, making ISO 2859-1 an appropriate standard for glove testing.

First, the glove batch size must be identified. Depending on the size and the selected inspection level, either 'Special Inspection Levels' (S1 to S4) or 'General Inspection Levels' (G1 to G3), the appropriate code letter is determined.

Special Inspection Levels are used when smaller sample sizes are justified — typically in lower-risk applications, cost-sensitive scenarios, or limited production runs. They provide a way to maintain efficiency without compromising basic quality control.

General Inspection Levels (G1 to G3) are more commonly used in high-volume manufacturing. They offer a balance between sample size and inspection rigour: G1 uses the smallest sample size, G2 is the industry standard, and G3 applies the most rigorous inspection with the largest sample size. This code letter then refers to the number of gloves that must be sampled for testing.

The table below (adapted from ISO 2859-1:1999) illustrates how code letters are assigned based on batch size and inspection level:

Understanding G1, G2 and G3 Inspection Levels

Here’s an example of how sample sizes vary for a batch of 10,000 gloves under different general inspection levels:

When Would You Use Each Inspection Level?

• G1: For non-critical applications or when you’ve got a good history of batch quality.
• G2: The industry default — a good balance of cost and confidence.
• G3: Used for higher-risk or more critical applications where increased sampling is required.

Glove Sampling Explained: ISO 2859-1 Tables for Batch Size, Inspection Levels, and AQL Limits

Selecting the Desired AQL and Inspection Level

The desired AQL value and inspection level are selected based on acceptable defect levels and the level of risk associated with the application.

AQL values are typically expressed as percentages (e.g. 0.25, 0.65, 1.5, 4.0) and define the maximum allowable number of defects in a sample.

Inspection levels (e.g. G1, G2, G3, S1–S4) determine the sample size taken from a batch, rather than the allowable defect rate.

Inspection levels (G1, G2, G3, S1–S4) define how many samples are taken from a batch, not how strict the AQL is. It's chosen based on risk level, product importance, and history of batch performance, not based on AQL.

So, a manufacturer might use:

• AQL 1.5 and G1 — for routine quality testing
• AQL 0.65 and G3 — in a high-risk environment requiring larger sample sizes

Table A (adapted from ISO 2859-1:1999) illustrates how code letters are assigned based on batch size and inspection level:

(Table A)

(Table B)

Table B shows the number of samples to choose, based on the code letter;

The AQL limits, based on the sample size selected from Table A, are shown as percentages (e.g. 1.5%, 2.5%, or 4.0%) and matched with corresponding acceptance and rejection numbers. This tells the inspector how many defective items are allowed before the batch fails.

Example: Glove Sampling Process Using ISO 2859-1

Scenario:

A manufacturer produces a batch of 50,000 disposable gloves. The gloves are being tested as PPE under EN ISO 374-2, and the manufacturer chooses General Inspection Level G1 with an AQL of 1.5%.

Step 1: Identify Code Letter (Table A)

From Table A, locate the row for batch size 35,001 – 150,000 under G1:

• Code letter = L

Step 2: Find Sample Size and Defect Limits (Table B)

Now go to Table B and look for code letter L in the left-hand column. Then find the column for AQL = 1.5%:

• Sample size = 200 gloves
• Acceptance number (Ac) = 7
• Rejection number (Re) = 8

What the Inspector Does:

• Randomly selects 200 gloves from the 50,000-batch.
• Performs a leak test (air or water) on each glove.
• Counts any gloves that fail.

Decision:

• If 7 or fewer gloves are defective → Batch is accepted
• If 8 or more are defective → Batch is rejected

4.5 How Sampling Sizes Are Determined in Medical Glove Manufacturing (EN 455-1)

In medical glove manufacturing, sampling sizes are determined using a fixed sampling plan defined in EN 455-1, which references ISO 2859-1:1999 but simplifies the process for clarity and consistency. This approach is specifically designed for medical examination and surgical gloves and does not use variable inspection levels like G1, G2, or S-levels.

The number of gloves to be tested is based solely on the batch size, and each batch is assigned a code letter. This code letter determines the sample size and the maximum number of allowable defects for a given AQL level — usually AQL 1.5 for examination gloves and AQL 0.65 for surgical gloves.

These values are taken from standardised acceptance tables built into EN 455-1 and ensure consistent, statistically valid results across all medical glove manufacturers. Unlike PPE glove sampling under EN ISO 374-2, this method does not vary based on inspection level or risk category — it’s fixed and uniform across the industry.

4.6 MD vs. PPE Glove Sampling: What’s the Difference?

Although both MD and PPE glove sampling procedures reference ISO 2859-1:1999, there are key differences in how they are applied. PPE gloves commonly use General Inspection Level 1 (G1) and require a minimum AQL of 1.5%. In contrast, EN 455-1 applies a fixed code letter system — for example, a batch of 400,000 medical gloves corresponds to code letter “L,” with a sample size of 200 and acceptance/rejection thresholds of 7 and 8. Under the same batch size in PPE (code letter “M”), the sample size would be 315, with acceptance/rejection at 10 and 11. This indicates that medical gloves may follow stricter sampling criteria in certain scenarios, reflecting their clinical application and higher safety requirements.

Key Differences Between MD and PPE Glove Sampling: 

• EN 455-1 uses a fixed sampling plan; EN ISO 374-2 uses variable inspection levels (e.g. G1). 
• Medical glove testing allows fewer defects than PPE glove testing. 
• EN 455-1 is tailored for microbial and patient safety; EN 374-2 focuses on chemical and mechanical protection.
• EN 455-1 does not use G1/G2/G3; EN 374-2 applies these ISO-based levels. 
• The sample size may be smaller in EN 455-1 but the acceptance criteria are stricter.

Tightened, Normal, and Reduced Inspection Levels 

ISO 2859-1:1999 includes guidance on tightened, normal, and reduced inspection levels. These levels adjust over time depending on recent batch quality.

• If several consecutive batches pass (typically 5), the inspection level can be reduced. This means fewer gloves are sampled.
• If multiple batches fail (typically 2), inspection is tightened, keeping the same sample size but applying stricter acceptance criteria.

5. Mechanical Protection – EN 388

EN 388 applies to protective gloves designed to protect the wearer against a range of mechanical hazards. The standard defines test methods and performance levels that allow gloves to be assessed and compared based on their resistance to common physical risks encountered in industrial and maintenance environments.

5.1 Mechanical hazards covered

EN 388 evaluates glove performance against the following mechanical hazards:

• Abrasion resistance – resistance to wear caused by rubbing against rough surfaces.
• Blade cut resistance – resistance to cutting by sharp edges or tools.
• Tear resistance – resistance to tearing when force is applied.
• Puncture resistance – resistance to penetration by sharp pointed objects.

Under EN 388:2016, an additional straight blade cut resistance test (ISO 13997) may also be applied where appropriate. Results from this test are expressed as levels A–F and are shown separately from the circular blade cut result.

EN 388:2016 also introduced optional impact resistance testing. Where a glove has been tested and meets the impact protection requirements, the letter “P” is displayed beneath the EN 388 pictogram.

5.2 Performance ratings explained

Each mechanical hazard covered by EN 388 is tested independently and assigned a performance level. These levels allow users to understand how well a glove performs against each specific risk rather than relying on a single overall score.

Performance levels are expressed numerically or alphabetically, depending on the test method used, and are displayed beneath the EN 388 pictogram. Higher performance levels indicate greater resistance to the tested hazard.

5.3 Changes introduced in EN 388:2016

The EN 388:2016 update introduced three significant changes to how protective gloves are tested for mechanical hazards. These updates affect abrasion resistance, cut resistance, and impact protection, ensuring a more accurate and reliable assessment of glove performance. Below is a breakdown of these key changes.

Abrasion Resistance – New Testing Method

• Under EN 388:2016, abrasion resistance testing now uses a new type of abrasive paper, which differs from the material previously used under EN 388:2003.
• Due to this change, gloves may receive a lower abrasion resistance score than before, even if their protective properties remain unchanged.
• Why This Matters: If a glove’s abrasion resistance rating appears lower under EN 388:2016 compared to EN 388:2003, it is due to the revised testing material rather than a decline in durability.

Cut Resistance – Introduction of a Second Test Method

A major revision in EN 388:2016 is the addition of a second cut resistance test. Previously, gloves were tested only with a circular blade cut test, but now they are also assessed using the ISO 13997 straight blade cut test.

5.4 Circular blade vs ISO 13997 cut testing

How Gloves Are Rated:

• Some gloves will receive both circular and straight blade cut scores.
• Other gloves may only receive a straight blade cut rating if the circular blade test is not performed.

Interpreting cut resistance results

• EN 388:2016 introduced updated cut resistance testing to reflect different cutting hazards found in real working environments.
• Results obtained under EN 388:2016 should not be directly compared with results from earlier versions of the standard due to changes in test methods.
• The circular blade test assesses resistance to repeated, low-force cutting, while the ISO 13997 straight blade test assesses resistance to single, high-force cutting events.
• Gloves may therefore display different cut resistance ratings depending on the test method used, without indicating a reduction in protective performance.

5.5 Impact protection marking (“P”)

Under EN 388:2016, gloves that are designed to provide impact protection may be tested to verify those properties. Impact testing is optional and applies only to gloves incorporating protective reinforcements intended to absorb or reduce impact forces.

Where a glove is tested and meets the impact resistance requirements, the letter “P” is displayed beneath the EN 388 pictogram. If impact testing is not performed, or if the glove is not designed to provide impact protection, this position in the marking remains blank. The absence of a “P” does not indicate non-compliance; it simply confirms that impact protection has not been assessed or claimed.

EN 388:2016 introduced changes to mechanical risk testing methods that affect how performance results are generated and interpreted.

• Abrasion resistance testing uses a revised abrasive material, which can result in different performance levels compared with earlier versions of the standard.
• Cut resistance may be assessed using either the circular blade test, the ISO 13997 straight blade test, or both, depending on glove design and intended use.
• Impact resistance testing is available for gloves incorporating impact-protective features and is identified by the “P” marking when applicable.

These changes improve alignment between test methods and real-world mechanical hazards, but performance results should always be interpreted in the context of the specific test methods applied.

6. Electrostatic & ESD Protection

6.1 What is electrostatic discharge (ESD)?

Electrostatic discharge (ESD) is the sudden transfer of electrical charge between objects at different electrical potentials. In industrial environments, this discharge can occur when static electricity accumulates on materials or personnel and is then released through contact or proximity to a conductive surface.

While often unnoticed in everyday settings, ESD can present a significant risk in workplaces handling sensitive electronic components or flammable substances.

6.2 Why ESD matters in industry and cleanrooms

Uncontrolled electrostatic discharge can cause damage or safety issues across several industries:

• Electronics and semiconductor manufacturing – ESD can damage or destroy microelectronic components, leading to yield loss and product failure.
• Chemical and pharmaceutical processing – Static discharge can act as an ignition source in environments containing flammable vapours or powders.
• Cleanrooms and laboratories – ESD control must be balanced with contamination control, requiring gloves that limit particle release while managing static charge.

In these environments, gloves form part of a wider ESD control system rather than acting as a standalone protective measure.

6.3 EN 16350 – ESD requirements for gloves

EN 16350:2014 establishes electrostatic performance requirements specifically for protective gloves intended for use in explosive atmospheres (ATEX environments).

The standard:

• Uses the vertical resistance test method defined in EN 1149-2
• Applies glove-specific performance limits
• Requires a vertical resistance (Rv) of less than 1.0 × 10⁸ Ω

Compliance with EN 16350 indicates that a glove is capable of dissipating electrostatic charge rather than allowing it to accumulate. EN 16350 is the relevant standard for gloves intended for use in explosive atmospheres (ATEX environments). In other applications, ESD control may form part of a broader electrostatic control programme.

6.4 ESD glove material behaviour

The electrostatic behaviour of gloves is influenced primarily by material composition. Glove materials are generally categorised by resistivity:

Nitrile gloves are commonly used in ESD-sensitive environments due to their chemical resistance and compatibility with cleanroom use. Where electrostatic control is required, gloves must be tested and verified for suitable electrostatic properties.

7. Cleanroom & Laboratory Glove Requirements

7.1 ISO 14644 cleanroom classification

ISO 14644 defines the classification of cleanrooms and clean zones based on the concentration of airborne particles within a defined volume of air. Cleanroom classes are expressed numerically (e.g. ISO Class 5, ISO Class 7), with lower numbers indicating stricter particle limits.

While ISO 14644 does not specify requirements for personal protective equipment, it provides the environmental framework within which cleanroom gloves must operate. Gloves selected for cleanroom use must not introduce particulate or chemical contamination that could compromise the cleanliness classification of the environment.

For a more detailed explanation of cleanroom classification and the ISO 14644 series, see our dedicated Cleanroom Guide:

Cleanroom Guide

7.2 ISO-based vs GMP cleanrooms

Cleanroom glove requirements vary depending on whether the environment operates under an ISO-based quality system or Good Manufacturing Practice (GMP).

• ISO-based cleanrooms are commonly used in industries such as electronics, microelectronics, aerospace, and optics. The primary objective is protection of the product from particulate contamination.
• GMP cleanrooms are used in pharmaceutical and biotechnological manufacturing, where regulatory requirements extend beyond particle control to include microbial contamination and sterility assurance.

Although both systems may reference ISO 14644 for airborne particle classification, GMP cleanrooms impose additional regulatory controls that influence glove selection, processing, and handling.

7.3 Cleanroom glove expectations

Regardless of the cleanroom standard applied, gloves used in cleanroom and laboratory environments are expected to support contamination control rather than personal hazard protection alone.

Typical expectations include:

• Low particle and fibre release
• Minimal extractable contaminants
• Compatibility with the cleanroom class in which they are used
• Consistent quality and traceability

In GMP environments, gloves may also be required to be sterile, validated, and subject to defined change and disinfection procedures. In ISO-based environments, sterility is not always required, but cleanliness and material behaviour remain critical.

7.4 IEST-RP-CC005.4 testing and selection guidance

IEST-RP-CC005.4 is a recommended practice that provides guidance on the selection, testing, and use of gloves in controlled environments. While not a regulatory standard, it is widely referenced in cleanroom industries as a benchmark for glove cleanliness and suitability.

The document addresses:

• Evaluation of glove materials for controlled environments
• Cleanliness testing methods
• Packaging considerations
• Handling and donning practices
• Documentation and traceability

IEST-RP-CC005.4 is particularly relevant in ISO-based cleanrooms where glove selection is driven by contamination control rather than sterility requirements.

7.5 Particle, extractables, and residue control

Cleanroom gloves are commonly assessed for their potential to introduce contaminants into controlled environments. Key considerations include:

• Particle release – the number and size of particles shed from the glove surface during use.
• Extractables – chemical substances that may leach from glove materials.
• Non-volatile residues (NVR) – residues left behind on surfaces after glove contact.
• Chemical residues – substances such as silicones or plasticisers that may interfere with sensitive processes.

Control of these factors is essential in cleanrooms where product performance, yield, or regulatory compliance can be affected by trace contamination. Glove selection must therefore consider not only protective performance, but also material behaviour within the cleanroom environment.

8. Supported vs Unsupported Gloves

8.1 What are supported gloves?

Supported gloves are reusable gloves constructed with a textile liner that provides structural support. The liner is typically made from materials such as cotton, polyester, nylon, or aramid fibres and is coated with a protective layer.

The liner:

• Supports the glove’s shape
• Improves durability and mechanical strength
• Enhances resistance to abrasion, tearing, and puncture

The external coating provides protection against specific hazards depending on material selection, such as oils, chemicals, or mechanical wear.

Supported gloves are commonly used in industrial, mechanical, and maintenance environments, where durability and mechanical protection are prioritised over fine dexterity or contamination control.

8.2 What are unsupported gloves?

Unsupported gloves are manufactured from a single material without a textile liner. They are typically produced by dipping hand-shaped formers into liquid polymer compounds and curing the material to form a seamless glove.

Key characteristics include:

• Thin, flexible construction
• High tactile sensitivity and dexterity
• Limited mechanical protection compared to supported gloves

Unsupported gloves are frequently single-use and are widely used in cleanrooms, laboratories, healthcare, and electronics manufacturing, where contamination control, hygiene, and precision handling are critical.

8.3 Comparison table

8.4 Typical applications by environment

Cleanrooms

• Unsupported gloves are typically preferred
• Low particle shedding materials
• Often cleanroom-processed and double-bagged
• Textile liners are generally avoided because of contamination risk

Electronics and semiconductor manufacturing

• Primarily unsupported gloves
• Selected for contamination control and electrostatic behaviour
• ESD-compliant versions used where required

Laboratory environments

• Unsupported gloves for precision handling and hygiene
• Supported gloves may be used for heavier chemical or cleaning tasks outside controlled areas

Industrial and manufacturing environments

• Supported gloves used for mechanical protection
• Selected based on cut, abrasion, puncture, or chemical resistance requirements

9. Specialist Applications

Certain environments present hazards that go beyond general chemical, mechanical, or cleanroom risks. In these cases, glove selection is governed by specialist standards that address radioactive contamination and ionising radiation. The primary standard covering these applications is EN 421:2010.

9.1 Radioactive contamination protection

Gloves intended to protect against radioactive contamination are designed to prevent the transfer of radioactive particles to the wearer’s skin. These gloves act as a barrier to contamination, rather than providing shielding against ionising radiation itself.

EN 421:2010 applies to gloves used in environments where radioactive contamination is present. For this application, gloves must provide reliable barrier performance to prevent radioactive contaminants from passing through the glove.

Key requirements include:

• Compliance with EN ISO 21420 for general glove safety, design, and information requirements
• Barrier integrity verified through penetration testing, ensuring the glove does not allow liquids or contaminants to pass through
• Appropriate quality control, typically assessed using AQL-based sampling methods to confirm consistent barrier performance

Where mechanical protection is claimed, relevant mechanical performance requirements may also apply. If no mechanical protection is provided, this must be clearly stated by the manufacturer.

These requirements ensure that gloves used in radioactive environments provide an effective barrier against contamination while maintaining suitable performance for handling tasks.

9.2 Ionising radiation gloves

Gloves intended to protect against ionising radiation are designed to reduce exposure to radiation by incorporating materials that provide a degree of shielding. Unlike gloves used solely for contamination control, these gloves are intended to attenuate radiation, as well as prevent the transfer of radioactive particles.

EN 421:2010 applies to gloves used in environments where ionising radiation is present. In addition to the requirements for radioactive contamination protection, gloves designed for radiation shielding must include materials capable of reducing radiation exposure.

Key requirements include:

• Compliance with EN ISO 21420 for general glove safety, design, and information requirements
• Barrier performance equivalent to contamination protection requirements, ensuring resistance to penetration by hazardous substances
• Incorporation of shielding materials, such as lead or equivalent compounds, to reduce radiation exposure
• Verification of shielding performance, typically expressed as a lead equivalent value

These gloves are used in specialised environments where radiation exposure presents a direct risk, such as nuclear facilities, radiological laboratories, and controlled research settings.

9.3 When EN 421 is applicable

EN 421:2010 applies specifically to protective gloves intended for use in environments where there is a risk of:

• Radioactive contamination, or
• Exposure to ionising radiation

The standard is only relevant where these hazards are present. It does not apply to gloves used solely for protection against chemical, biological, mechanical, or cleanroom contamination risks.

In practice, EN 421 is typically applicable in:

• Nuclear and radiological facilities
• Laboratories handling radioactive materials or isotopes
• Decontamination and waste handling operations involving radioactive substances

For applications where radioactive hazards are not present, glove selection should instead be based on the relevant standards for the specific risk, such as:

• EN ISO 374 (chemical protection)
• EN 388 (mechanical protection)
• EN 16350 (electrostatic performance)
• Cleanroom guidance and contamination control requirements