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510(k) Data Aggregation

    K Number
    K212994
    Device Name
    Medical Face Mask
    Date Cleared
    2022-01-17

    (119 days)

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

    Guangzhou Quantum Laser Intelligent Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The medical face masks are intended to be worn to protect both the patient and healthcare persomel 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, provided non-sterile.
    Device Description
    The Medical Face Masks are single use, flat-pleated, ear loop masks that are provided in blue. The medical face masks are available in three types, which are Level 1, Level 2 and Level 3 based on ASTM F2100-19, depending on marketing reasons. However, Level 2 and Level 3 masks are exactly the same. The outer and inner layers of the mask are made of spunbond polypropylene. The middle filter layer is made of meltblown polypropylene filter. The ear loops are made of nylon and spandex. The ear loops are held in place over the users' mouth and nose by two elastic ear straps. The nose of PE and galvanized iron wire. Users 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. The proposed devices are provided in non-sterile.
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