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510(k) Data Aggregation

    K Number
    K202323
    Device Name
    Disposable Medical Surgical Masks
    Date Cleared
    2021-02-02

    (169 days)

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

    Tianjin Teda Jinshan Easy Packing Manufacture Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable Medical Surgical Masks is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Single-Use Surgical Mask with Ear Loop 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 non-sterile.
    Device Description
    The Disposable Medical Surgical Masks 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 Masks 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 non-sterile. The proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Ear Loops' way for wearing, and they all have Nose Piece design for fitting the facemask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric. The Disposable Medical Surgical Masks is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with Polyurethane fiber and Nylon. The nose piece contained in the proposed device(s) is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PE and iron wire. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices. The proposed device(s) are meet the Level 3 Barrier requirements per ASTM F2100-19.
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