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510(k) Data Aggregation

    K Number
    K211576
    Device Name
    WYZ Surgical Mask
    Date Cleared
    2021-08-19

    (90 days)

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

    WYZ Medical Supplies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The WYZ Surgical Mask is intended to be worn to protect both the patient and healthcare personnel 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 a single use, disposable device(s), provided non-sterile.
    Device Description
    The proposed device (model: WYZ201) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose. The proposed devices are manufactured with three layers, the inner and outer layers are made of Polypropylene (PP) spun-bond, and the middle layer is made of Polypropylene (PP) melt-blown. The WYZ201 model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Elastic film based on styrene block copolymer (SBC) with polyolefin (PO) outer layer. Hotmelt based on styrene-isoprene block copolymers (SIS) Nonwoven on both sides based on polypropylene (PP) spun-bond. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Galvanized iron wire with PP+PE coating. The proposed devices are sold non-sterile and are intended to be single use, disposable device.
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