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510(k) Data Aggregation

    K Number
    K211378
    Device Name
    LM Surgical Mask Level 3, LM Surgical Mask Level 2,
    Manufacturer
    Date Cleared
    2021-12-16

    (226 days)

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

    Liberty Mask LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The following Liberty 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 masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These are single use, disposable device(s) provided non-sterile.
    Device Description
    The LM Surgical Masks are white, single use, three-layer, pleated masks that come in 2 models: LM Surgical Mask Level 3 & LM Surgical Mask Level 2. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene. The masks are held in place over the users' mouth and nose by either two elastic ear loops, welded to the facemask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. The nose piece is made of polypropylene coated steel wire. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
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