EN ISO 21420:2020

EN ISO 21420:2020 General standards for protective gloves 

BS EN 420 has been reviewed and replaced by a new standard EN ISO 21420:2020 ‘Protective gloves – General requirements and test methods’. As it is a ISO standard, this is now a Worldwide standard.

Scope

The requirements of the new standard cover all protective gloves; such as protective gloves; arm protectors; gloves fitted to containment enclosures, mittens and pot holders.

Application

As the PPE Regulation states, products must be ‘state-of-the-art’. Protective gloves will need to be tested in accordance with EN ISO 21420. This should be done in time for any new EU type-examination applications.

The standard focuses on key product safety and performance issues such as: 

• Innocuousness
• Size
• Dexterity
• Package marking
• Instructions for use

Key points from the new EN ISO 21420 standard:

General

The design and manufacture of gloves should ensure the product provides protection when used in accordance with manufacturer’s instructions, without harm to the end user.

Innocuousness

With the aim that protective gloves shall not adversely affect health, safety and hygiene of the end user, changes were made to the standard. This creates a greater alignment of Chemical testing with REACh Requirements. Key points that we should be aware of are:

• Any metallic materials that could come into contact with the skin shall not release nickel in more than 0.5µg/cm2 per week (Test method EN 1811)
• DMFa (dimethylformamide) shall not exceed 0.1% weight/weight (Test method prEN 16778)

Size

The standard has removed the requirement of minimal glove length requirements, unless required by a specific standard.

Product Labelling

Product labelling should include a date of manufacture markings, and improved information for users, additional information on donning/doffing, and advice on product integrity checks before use.

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BS EN 455 – European Standard for Medical Gloves

In order for a product to be used in a medical environment, it is essential that the product meets the tough requirements of the EN 455 test.

BS EN 455-1: 2020 Freedom from holes. 

Testing for this standard uses a water leak test that is carried out using AQL statistical sampling techniques based on production batch sizes. Gloves used in a medical setting require an AQL of 1.5, which is a maximum of 1.5% product failure.

This is important in the real world, as this helps to reassure users that the gloves are thoroughly checked for holes, providing an effective barrier from exposure to chemicals or biological contaminants, when they need protection.  

BS EN 455-2: 2015 Physical Properties. 

This covers testing such as dimensions (length & width) and force at break both before and after heat ageing.

This testing ensures that Gloves conform with uniform sizing specifications, so that the correct size can be selected by the user. The force at break is important to ensure that gloves are strong enough for their appropriate use, and that users can don and use the gloves with confidence. Whilst the actual physical testing requirements of the glove depend on the specification and material that the glove is made of, this testing ensures the user receives good quality product. 

BS EN 455-3: 2015 Biological evaluation. 

Biological evaluation of endotoxins, powder residue and leachable proteins is important in safeguarding the user’s skin health during use. Endotoxins is a measure of chemicals left by harmful bacteria, and is important to surgical gloves. 

Powder free gloves should ensure less than 2mg powder per glove, to ensure that the glove is suitable for that claim.

Measurement of leachable proteins is relevant for Natural Latex products, which have natural proteins and enzymes, where it is well documented that susceptible individuals may have allergic skin reactions during use of the gloves. 

Chemical residue testing, commonly using ISO10993, ensures that users skin is not exposed to harmful chemicals during wearing of the glove. Chemicals can cause skin reactions and dermatitis (Type IV allergic reactions) in susceptible individuals.

BS EN 455-4: 2009 Requirements and testing for shelf-life determination.

It is important to test the shelf life of products, so that an effective expiry date can be given. This gives users confidence that the glove will be of good quality whilst in date. 

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BS EN ISO 374 – Protective Gloves against Chemicals and Microorganisms

Testing is required for Disposable Examination Gloves to validate their safety when in contact with Chemicals and Microorganisms and / or viruses. For each Glove type there is a clear indication of the chemicals and / or Microorganisms that the Gloves will protect against.

BS EN ISO 374 has several parts. The following parts are relevant for chemical protective gloves:

• Part 1: Terminology and performance requirements for chemical risks.
• Part 2: Determination of resistance to penetration
• Part 3: Determination of resistance to permeation by chemicals has been superseded by BS EN 16523-1:2015 A1: 2018 and is no longer in use.
• Part 4: Determination of resistance to degradation by chemicals 
• Part 5: Terminology and performance requirements for Micro-organisms risks

Users will see symbols on pack, which show what the Glove is suitable for. The advantage for users is that it is very clear what chemicals have been tested and what the glove will protect against, giving transparent information for the users to choose their best Glove option.

BS EN ISO 374-1 Terminology and performance requirements for chemical risks. 

Testing is conducted externally, with gloves being subjected to a series of chemicals. Test results are shown on pack by the Pictogram, Classes and Letters describe how effectively the Glove protects against chemicals during testing:

The letter symbols are given in the table below. The aim of the test is to cover as many types of chemical as possible in the test to ensure safety.

BS EN ISO 374-2 Determination of resistance to penetration

This test involves an air and water leak tests. The standard publishes strict AQL limits that the glove manufacturer must comply with during routine Quality Control. 

BS EN ISO 374-3:2003 Determination of resistance to permeation by chemicals - PART WITHDRAWN 

Replaced by test method BS EN 16523-1:2015 A1:2018 ‘Determination of material resistance to permeation by chemicals. Part 1: Permeation by liquid chemical under conditions of continuous contact’.

BS EN ISO 374-4 :2013 Determination of resistance to degradation by chemicals

A mandatory test for all gloves that offer chemical protection. The puncture resistance of the glove material is measured after continuous contact of its external surface with a challenge chemical. 

BS EN ISO 374-5: Terminology and performance requirements for Micro-organisms risks

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