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