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510(k) Data Aggregation

    K Number
    K212471
    Device Name
    Medical Face Mask
    Manufacturer
    Haian Medigauze Co., Ltd
    Date Cleared
    2021-11-04

    (90 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Haian Medigauze Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.
    Device Description
    The medical face mask is designed and manufactured by Haian Medigauze Co., Ltd . It is non-sterile and for single use. The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device, which is made from steel wire, allows the user to fitthe face mask around their nose. The product is level 1 according to ASTM F2100-19.
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