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510(k) Data Aggregation

    K Number
    K212726
    Device Name
    Disposable Medical Surgical Mask
    Date Cleared
    2022-03-23

    (208 days)

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

    Hubei Huaqiang High-Tech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided sterile.
    Device Description
    The Disposable Medical Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Disposable Medical Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device(s), provided sterile. The proposed device(s) are Blue color, and Flat Pleated type mask(s), utilizing Ear Loops to secure to the users head and a pliable Nose Piece for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene melt-blown fabric. The Medical Surgical Masks-Sterile is held in place over the users' mouth and nose by two elastic ear loops affixed to the facemask. The elastic ear loops are made with nylon or spandex. The nose piece contained in the proposed device(s) is contained within the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polypropylene and metal wire. The proposed device(s) are sold sterile and are intended to be single-use, disposable devices.
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