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510(k) Data Aggregation

    K Number
    K210015
    Device Name
    Surgical Face Mask
    Date Cleared
    2021-06-10

    (157 days)

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

    Sample King Manufacturing Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The surgical face mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The 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
    Surgical Face Mask is composed of a mask body, a nose clip, and two ear ropes. The mask body of ear loop type has three layers in structure: the inner and outer layers are made of polypropylene non-woven fabrics, and the middle layer is made of polypropylene melt-blown cloth. The component ratio is 24.5% melt blown cloth and 71.5% PP non-woven. The nose clip contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PE. The ear ropes are made of nylon and spandex. This is a single use, disposable device(s), provided non-sterile.
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