Gloves have to meet the requirements which can certification?
Home » NEWS » How to Choose Gloves » Gloves have to meet the requirements which can certification?

 +86 18819765380

Gloves have to meet the requirements which can certification?

Views: 845     Author: Yiliya     Publish Time: 2022-07-16      Origin: Site

facebook sharing button
twitter sharing button
line sharing button
wechat sharing button
linkedin sharing button
pinterest sharing button
sharethis sharing button

    Medical gloves exported to the EU need to meet the requirements of MDR EU No.2017/745 medical devices regulation.

    Common medical gloves: examination gloves, surgical gloves, laboratory gloves, chemical gloves, mostly disposable gloves.

    Common medical gloves materials: Latex, PVC, Nitrile, and composite gloves.

    According to Appendix VIII of the MDR Regulation:

    Non-sterilized medical gloves belong to class I medical devices,Sterilized medical gloves belong to class II of medical devices.

    Standards for CE certification of medical gloves:

    ●EN 455-1: Testing and testing of sealability

    ●EN 455-2 Physical performance tests

    ●EN 455-3 Biological evaluation: tests for sterility, endotoxin, water-soluble protein, dust residue and biocompatibility

    ●EN 455-4 Validation of shelf life (Determination of shelf life)



    Gusiie production of gloves:

    High quality raw materials

    ★Production technology leading the international level

    ★Through international certification, in line with international quality standards

Being one of the most professional suppliers of disposable gloves in China, we are devoted ourselves to the safe products and best service.



   +86-18819765380
  Room 302, No.15, Lianfeng North Road,                    Chang'an Town, Dongguan City, Guangdong          Province, China
© 2021 DONGGUAN GUSIIE PROTECTIVE PRODUCTS CO., LTD . All rights reserved. Support By Leadong  Sitemap