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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Medical Devices

Medical Device legislation is the regulatory framework for all Medical Devices; including Examination Gloves.

Medical Device Regulation (MDR) EU 2017/745

The Medical Device Regulation (EU) 2017/745 is a new regulation, which replaced the Medical Devices Directive, 93/75/EEC, as well as the Implantable Medical Device Directive, in Europe, entering law on the 26^th May 2021. This law is also effective in Northern Ireland due to the provisions of the Northern Ireland agreement between the EU and the UK following BREXIT.

The legislation adopted at EU level aims to safeguard the safety and health of patients and medical personnel alike, the economic and legal interests of healthcare providers and consumers, as well as offering redress and general product safety systems. The laws protect patients and medical personnel from risks that they would ordinarily not have the power to tackle; empower individuals to make clear product choices; ensure a clear and consistent approach to product claims and information; and bring about measures that directly safeguard people.

The changes to the regulatory regime in the EU was brought about in response to the PIP Breast Implant scandal, where subsequent investigations found not only fault with the manufacturer, but also significant short fallings in product surveillance and notified body monitoring. 

As a result, the EU 2017/745 Medical Device regulation is much larger, with 100 more articles, much more prescriptive, and brings in new rules aimed at safeguarding patient safety.

Some of the key changes are listed below: 

• Unique Device Indicator (UDI) to be phased in
• Increased Post Market Vigilance 
• Authorised Representatives are now jointly responsible for the product with Manufacturer
• Unannounced Audits & Regulatory screening
• Requirements for a manufacturer to have a Quality Management System
• Person responsible for Regulatory compliance

UK Medical Device Regulation 2002, as amended

Following the UK’s withdrawal from the EU, the EU regulation EU 2017/745 was not implemented, due to the delay in implementation following the Coronavirus Pandemic. The Medical Device Regulation 2002 is based on the now withdrawn EU Medical Device Directive, 93/42/EEC. 

To encourage a higher level of patient safety, additional requirements were brought in to this regulation however, such as strengthened requirements relating to post-market surveillance of products and Unique Device Indicator (UDI). 

UK CA Marking

Having withdrawn from the EU, the UK has defined the regime for approval of medical devices. The UK requires that a UK CA mark is applied following conformance with regulatory requirements. This will be phased in for all UK products, depending on product type.

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