Disposable glove testing & certification services

Disposable gloves can be Medical Devices, Personal Protective Equipment (PPE) or both, as per the European Regulation of medical devices and PPEs Regulation. We offer disposable gloves testing per European market standards and U.S. market standards.

PPE certification for disposable gloves

As Category III PPE, disposable gloves must undergo certification by an EU Notified Body. Our lab in Spain is a Notified Body (2865), offering:

• Conformity to type based on internal production control (Module C2)
• Conformity to type based on quality assurance (Module D)

Medical gloves testing for chemical & biological risks (EU)

Gloves used for chemical and biological protection must meet EU Regulation 2016/425, including:

• EN ISO 21420 – General requirements
• EN ISO 374 series – Protection against chemicals & microorganisms
• EN 16523-1 Chemical permeation
• ISO 16604 (Procedure B) – Virus protection (optional)

Medical gloves for infection control (EU)

EU Standards (Medical Devices Directive 93/42/EEC)

• EN 455 series – Covers durability, safety, and biological evaluation

U.S. Standards (ASTM)

• ASTM D6319 – Nitrile gloves
• ASTM D3578 – Rubber gloves
• ASTM D5250 – Vinyl gloves
• ASTM D3577 – Surgical gloves

Food contact & single-use nitrile gloves testing

• Food Contact Gloves – Tested under EN 1186 for migration of substances into food
• Single-Use Nitrile Gloves – Testing to ISO/IEC 17025:2017 and testing of water and air leakage against ISO 374

Notified body & CE marking services

CE marking is mandatory for PPE in Europe. As an ISO 17025-accredited Notified Body, Eurofins Textile Testing Spain, S.L.U. provide testing and certification services to ensure compliance with EU Regulation 2016/425.