Medical gloves for single use - Part 1: Requirements and testing for freedom of holes
Covers requirements and tests for freedom from holes in single-use medical gloves.
The text of this standard is sold by CEN and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| European Union | Harmonized | EN 455-1:2020+A2:2024 | - | Recognition number MDR entry 27. Effective April 9, 2025. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
| United Kingdom | Recognized | EN 455-1:2020+A2:2024 | - | Recognition number List row 2. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: IEC 60118-0, ISO 80369-2, EN 455-2, EN 13795-1, EN 13795-2, EN 14683, ISO 7197, ISO 14630, ISO 21535, ISO 21536, ISO 14607, ISO 1135-4. See .
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.