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510(k) Data Aggregation

    K Number
    K220512
    Device Name
    Disposable Surgical Face Mask (M01, M02)
    Date Cleared
    2022-04-25

    (62 days)

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

    Fomed Industries Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Disposable 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 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(s), provided non-sterile.
    Device Description
    The Disposable Surgical Face Mask is blue color, single use, that-folded masks with nose piece and ear loops or ties. The blue colorant is polypropylene (PP) master batch. The body of the mask is composed of three layers: the inner and outer layers are made of polypropylene spun-bond nonwoven fabric, and the middle layer is made of polypropylene melt blown non-woven fabric. The nose clip is made of galvanized iron wire coated by polypropylene (PP), ear loop is made of Nylon and Spandex, and the ties are made of polypropylene spun-bond nonwoven fabric. The size of surgical face masks is 17.5*9.5cm with tolerance±5%, the length of the ear loop is about 15.5cm to 16.5cm, and the length of the ties is 40 cm. The disposable surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
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