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• Part 3: Determination of resistance to permeation by chemicals has been superseded by BS EN 16523-1:2015 A1: 2018 and is no longer in use.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BS EN ISO 374-3:2003 Determination of resistance to permeation by chemicals - PART WITHDRAWN 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

We are happy to help!

For further help, or information contact your local Supermax Sales Manager, or e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.. For Quality, Regulatory and technical issues contact This email address is being protected from spambots. You need JavaScript enabled to view it.

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.

We are happy to help! 

For further help, or information contact your local Supermax Sales Manager, or e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.. For Quality, Regulatory and technical issues contact This email address is being protected from spambots. You need JavaScript enabled to view it.

PPE Regulation (EU 2016/425)

Examination Gloves must commonly satisfy two regulations within the EU and UK. Products will comply with the PPE Regulations (EU 2016/425) and the Medical Device Regulations (2017/745), and Medical Device Regulation 2002. This regulatory compliance ensures the Gloves comply with tough regulatory requirements, giving the user reassurance of the upmost safety in use.

Personal Protective Equipment (PPE) Regulation (EU) 2016/425

The Personal Protective Equipment (PPE) Regulation (EU) 2016/425, which has been adopted directly into UK law, 2016/425, which legislates the making available of PPE to the market. The purpose of the regulation is to ensure the safety of PPE users by the provision of validated, safe, reliable and quality products, with transparency on testing and product capabilities.

Product Risk Categories

Aurelia range of Nitrile and Latex Examination Gloves are Category III PPE, whereas the Aurelia Vinyl and TPE gloves are Category I PPE. 

Product Conformity Routes

Depending on the Risk Category of the product, there are defined routes to product conformity. Category I products require the company to produce a Declaration of Conformity and maintain Technical Documentation. Category III products require an EC Type Examination Certificate (Module B), either a Quality Control monitoring of products (Module C2), or a Production Quality System Audit (Module D) from a Notified body, and technical Documentation to be maintained for the product. A Declaration of Conformity can then be created. 

CE and UK CA marking

CE marked Category III products require for the Module D notified body number to be labelled on pack. UKCA marked require the same with approved body number labelled.

We are happy to help! 

For further help, or information contact your local Supermax Sales Manager, or e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.. For Quality, Regulatory and technical issues contact This email address is being protected from spambots. You need JavaScript enabled to view it.