Gloves have to meet the requirements which can certification?

    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