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510(k) Data Aggregation

    K Number
    K212293
    Device Name
    Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
    Date Cleared
    2021-10-25

    (95 days)

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

    Jiangmen Ningrui Medical Supplies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Mask (Model: WK1701-02A, WK1701-03A and WK1701-04A) is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The 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 non-sterile. The Model WK1701-02A is Level 1 barrier as ASTM F2100 requirements. The Model WK1701-03A is Level 2 barrier as ASTM F2100 requirements. The Model WK1701-04A is Level 3 barrier as ASTM F2100 requirements.
    Device Description
    The proposed device(s) includes 3 models, which are WK1701-02A, WK1701-03A and WK1701-04A. Three of them all 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. All three models of proposed device(s) share same materials and structure, they all are manufactured with three layers, the inner and outer layers are made of polypropylene spunbond fabric, and the middle layer is made of polypropylene meltblown fabric. The proposed device(s) of Level 1, Level 2 and Level 3 have the same material. 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 meltblown fabric. 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 polypropylene coated galvanized iron wire. The proposed device(s) 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 made with nylon and spandex. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
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