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510(k) Data Aggregation

    K Number
    K202161
    Device Name
    Surgical Face Mask
    Date Cleared
    2021-03-10

    (219 days)

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

    **Hunan EEXI Technology **& Service Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Face 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 use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
    Device Description
    The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, YX011, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The model of proposed device, YX121, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene and iron. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
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    K Number
    K202439
    Device Name
    Disposable Medical Face Mask
    Date Cleared
    2021-03-08

    (195 days)

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

    **Hunan EEXI Technology **& Service Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These mask are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use , disposable device, provided nonsterile.
    Device Description
    The proposed devices are single use, three-layer, flat masks with ear-loops and nose piece. The Disposable Medical Face Masks are manufactured with three layers, the outer layer is made of PPSB non-woven fabric, which the chemical composition is the mixture of Polypropylene and color master batch. Inner layer is made of Polyethylene, polypropylene and mixture of fiber finishes. And the middle layer is made of melt blown polypropylene filter. The model of proposed device ,YX001, is held in place over the user's mouth and nose bu two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable aluminum wire. The proposed devices are sold non-sterile and are intended to be single use, disposable devices. The colorants used for mask are Copper phthalocyanine and Titanium dioxide.
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