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510(k) Data Aggregation

    K Number
    K211097
    Device Name
    Banyan USA Surgical Mask Level 3
    Manufacturer
    Date Cleared
    2021-09-22

    (162 days)

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

    Banyan USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Banyan USA Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganism, body fluids, and particulate materials. This face mask are intended for use in infection control practices to reduce potential exposure to blood and body fluids. the face mask is single use, disposable device, provided non-sterile.
    Device Description
    The Banyan USA Surgical Mask is composed of three-layers which are flat-pleated and ultrasonically welded together at the edges of the mask at embossment points. The mask materials consist of an outer layer (polypropylene spunbond, white), filter layer (polypropylene melt-blown, white) and inner layer web (polypropylene thermal-bonded, white (22 GSM Thermal Bond White Material)). Each mask has two ear loops ultrasonically welded onto the sides to secure the users' nose and mouth. The construction also includes a polyethylene wire nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
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