Disposable glove certification
Ensuring compliance for disposable gloves
Comprehensive testing
Ensure your disposable gloves meet safety, quality, and compliance with testing for durability, barrier protection, and material integrity.
Reliable certification
Obtain global certification for disposable gloves. We ensure compliance with international medical and industrial safety standards.
Expert compliance guidance
Our specialists provide end-to-end support to help you meet regulatory, safety, and performance standards for your protective gloves.
Disposable glove testing and 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 and 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 and 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 and 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 and 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.
Disposable glove compliance is complex
We provide expert testing, certification, and compliance guidance to help you meet global safety standards efficiently, ensuring your gloves are market-ready and fully compliant.
What sets Eurofins Softlines & Hardlines apart?
Fast and reliable turnaround
We provide rapid, accurate testing results to help you meet compliance deadlines and bring products to market faster.
Tailored compliance support
Our customer-focused approach ensures seamless disposable glove testing and certification offering expert guidance and regulatory support at every step.
Industry-leading expertise
With deep regulatory knowledge and advanced testing capabilities, we help ensure your disposable gloves meet global safety and compliance standards.