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510(k) Data Aggregation

    K Number
    K212913
    Device Name
    Surgical Face Mask
    Date Cleared
    2022-01-14

    (123 days)

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

    Jiangxi Ganlong Pharmaceutical Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are 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 Surgical Face Masks are Flat Pleated type mask, utilizing Ear straps way for wearing, and they all have Nose clip design for fitting the face mask around the nose. The Surgical Face Masks are manufactured with three layers. The outer layer is made of polypropylene spun-bond non-woven fabric. The middle layer with filtration function is made of polypropylene melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene spun-bond non-woven fabric. The nose clip is made of polyethylene strip with iron wire inside. The ear straps are made of spandex polyester fiber. The Surgical Masks are single use, disposable device, provided sterile.
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