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510(k) Data Aggregation

    K Number
    K211984
    Device Name
    MASC Surgical Mask
    Date Cleared
    2021-07-25

    (30 days)

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

    Mid-America Safety Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MASC Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.
    Device Description
    The MASC Surgical Mask is a three-ply, nonwoven, flat pleated mask. The MASC surgical mask consists of an outer layer (polypropylene spun-bond, blue), a middle filter layer (Polypropylene melt-blown, white), and an inner layer (Polypropylene spun-bond, white). The three layers of the mask body are collated with ultrasonically welded edges and comes in two models, an ear- loop model (NFR03U-01A) and a tie-on model (NFR03U-01B). The polyester spandex blend ear loops or polypropylene tie-on band are ultrasonically bonded to the sides of the non-filtration area of the mask to secure the mask over the user's mouth, nose and chin. A malleable polyethylene coated wire nosepiece is placed within the top binding for comfort and individualized fit over the nose. The MASC Surgical Mask is a single use, disposable, nonsterile device which conforms to ASTM F2100-19 Level 3. This device does not contain any natural rubber latex or fiber glass materials.
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