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510(k) Data Aggregation

    K Number
    K212398
    Device Name
    Surgical Face Mask (Non-sterile)
    Manufacturer
    Hubei Kimsoul Industrial Co., Ltd
    Date Cleared
    2021-12-15

    (135 days)

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

    Hubei Kimsoul Industrial Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for adult use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
    Device Description
    The proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. It is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of polyester and polyurethane, not made from natural rubber latex. The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is made of polyethylene. The proposed device is provided non-sterile and is intended to be a single use, disposable device.
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