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510(k) Data Aggregation

    K Number
    K212575
    Device Name
    Surgical Face Mask
    Date Cleared
    2021-11-14

    (90 days)

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

    Hubei Huanfu Plastic Products Co., 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 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, provided non-sterile.
    Device Description
    The Surgical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and spandex, not made with natural rubber latex or fiberglass. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Iron core coated with PE. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
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