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510(k) Data Aggregation

    K Number
    K202548
    Device Name
    Surgical Face Mask
    Date Cleared
    2021-03-10

    (189 days)

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

    Wanxinda (Guangzhou) Technology Product Co., Ltd

    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 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 non-sterile.
    Device Description
    The proposed devices are single use, three-layer, flat masks with ear loops 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 proposed device, 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 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 polypropylene with steel wire. The colorants used for mask are Copper phthalocyanine, Titanium dioxide and Polyethylene. The proposed devices are sold non-sterile and are intended to be single use, disposable devices. The proposed device including two models, WXDKZ0001 and WXDKZ0006, the difference is the color of the outer layer.
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    K Number
    K202710
    Device Name
    Disposable Medical Face Mask
    Date Cleared
    2021-03-09

    (174 days)

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

    Wanxinda (Guangzhou) Technology Product Co., Ltd

    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 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 ear loops and nose piece. The Disposable Medical 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 proposed device, 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 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 polypropylene with steel wire. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
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