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510(k) Data Aggregation

    K Number
    K220824
    Device Name
    Medical Surgical Mask (Planar type)
    Date Cleared
    2022-05-19

    (59 days)

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

    Hunan Chopard Medical Devices Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The medical surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
    Device Description
    The Medical Surgical Masks are blue color, three-layer, flat-pleaded masks with nose piece and ear loops, which are composed of inner layer and outer layer. The colorant is blue polypropylene (PP) master batch. The inner layer and outer layer of the mask are made of non-woven fabric (polypropylene), the middle layer is made of melt-blown fabric (polypropylene). The ear loop of the subject mask is held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loop is made with polyamide and spandex. The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of polypropylene wrapped galvanized soft wire. The Medical Surgical Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks.
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