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: 2013..
  • EN374

 

 

Manufacturer:

ZHONGHONG PULIN MEDICAL PRODUCTS CO., LTD Chengxi Industrial Park, Luannan County, Tangshan City, CHINA