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510(k) Data Aggregation

    K Number
    K202640
    Device Name
    Surgical Mask
    Date Cleared
    2021-01-22

    (133 days)

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

    Jiangsu Medpure Biological Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. This face 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.
    Device Description
    The Surgical Mask is 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 mask is manufactured with three layers, the inner and outer layers are made of PP spun-bond non-woven, and the middle layer is made of Melt-blown non-woven fabric. The Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. Theelastic ear loops are made with Polyester fiber and Polyurethane. 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 Polyethylene and Metal Wire. The mask is sold non-sterile and are intended to be single-use, dis posable devices and the colorant used for mask is TiO2 + Phthalocyanine Blue BGS + Pigment Violet23.
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