EN 455
EN 455 is the standard series for medical single-use gloves and defines the minimum requirements that examination gloves, surgical gloves, and chemotherapy gloves must meet as medical devices under MDR (EU) 2017/745.
The series comprises four parts:
- EN 455-1: Leak resistance – water-leak test, AQL 1.5 (examination gloves) or AQL 0.65 (surgical gloves)
- EN 455-2: Physical properties – dimensions, minimum length, tensile strength, and elongation by material type
- EN 455-3: Biological evaluation – requirements for protein content (latex), residual chemicals, and cytotoxicity
- EN 455-4: Shelf life – accelerated ageing tests to determine the expiry date
Gloves compliant with EN 455 are Class I medical devices under MDR. They protect both user and patient but are not designed as chemical-resistant gloves – that application falls under EN ISO 374.
EN 455 and EN ISO 374 are designed for different use cases and are not mutually exclusive: a glove can comply with both standards simultaneously.
Frequently asked questions
What does EN 455 cover for medical gloves?
EN 455 defines minimum requirements for medical single-use gloves across four parts: leak resistance (EN 455-1), physical properties (EN 455-2), biological evaluation (EN 455-3), and shelf life (EN 455-4).