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510(k) Data Aggregation

    K Number
    K202214
    Device Name
    IFM Surgical Mask Model SM3
    Manufacturer
    Date Cleared
    2021-03-02

    (208 days)

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

    FSSC, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IFM Surgical Mask Model SM3 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
    Device Description
    The IFM Surgical Mask Model SM3 is composed of four-layers and is flat-pleated. The mask materials consist of an outer cover web (polypropylene spunbond, white), insertion layer (polypropylene, melt-blown, white), filter web (polypropylene melt-blown, white) and inner cover web (polypropylene melt-spunbond, white). Each mask contains ear loops to secure the mask over the user's mouth and nose and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile. This device is not made with natural rubber latex.
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