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510(k) Data Aggregation

    K Number
    K223068
    Device Name
    Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)
    Date Cleared
    2022-11-23

    (54 days)

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

    Guangdong Golden Leaves Technology Development Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide non-sterile.
    Device Description
    The subject device is a four-layer, single-use, flat-folded shape mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the filter (2 layers) is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and headband. The ear loops and headband are made of polyester. The nose clip is made of polypropylene and wire, user can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
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