Approvals & Certifications
MDD classification and compliance:
Directive 93/42 / EEC
Gloves are classified as class I medical devices in accordance with Annex VII of the Medical Device Regulation 2017/745 and comply with the standards:
- EN 455-1: 2000,
- EN 455-2: 2015
- EN 455-3: 2015
- EN 455-4: 2009
- EN ISO 15223-1: 2016
- EN 1041: 2008 A1: 20133
- EN 374
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