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510(k) Data Aggregation

    K Number
    K211552
    Device Name
    Surgical mask
    Date Cleared
    2021-08-11

    (84 days)

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

    Shandong Shengquan New Materials Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, and provided non-sterile.
    Device Description
    The Surgical Mask is a non-sterile, single use, and flat pleated mask with ear loops and nose clip. The product is manufactured with three layers, the inner layer is made of white polypropylene spunbond, the outer layer is made of black polypropylene spunbond (a common colorant named carbon black was added) and the middle layer is made of melt blown polypropylene filter. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The mask will be provided in black and white. The colour of outer layer is black. The colour of inner layer is white.
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