Examination Glove
Examination gloves (also: medical single-use gloves) are Class I medical devices under MDR (EU) 2017/745 and must comply with the EN 455 standard series (Parts 1–4).
Main materials: nitrile (most common), latex (high elasticity, allergen potential), vinyl (lower cost, lower tear strength), TPE (latex-free, plasticiser-free).
Requirements per EN 455:
- EN 455-1: AQL 1.5 (water leak test)
- EN 455-2: minimum length, dimensions per size, tensile strength (nitrile/latex ≥6 N, vinyl ≥3.6 N), elongation
- EN 455-3: biological safety (cytotoxicity, protein content for latex)
- EN 455-4: shelf life (accelerated ageing test)
Examination gloves are supplied NON STERILE as standard. They are not designed as chemical-resistant gloves – EN ISO 374 applies for that purpose. Where chemical resistance is required, gloves must additionally comply with EN ISO 374.
Gloves may be certified as both a medical device and PPE if they comply with both sets of standards.
Frequently asked questions
What is the difference between an examination glove and a surgical glove?
Can examination gloves also be PPE?
Yes. An examination glove can be simultaneously certified as a medical device (EN 455) and as PPE (e.g. EN ISO 374 for chemical resistance) if it complies with both standard sets and is labelled accordingly.
What materials are used for examination gloves?
Nitrile: latex-free, chemically resistant – standard material. Latex: high elasticity, allergen potential. Vinyl (PVC): lower cost, lower mechanical strength. TPE: latex-free and plasticiser-free.