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.
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