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510(k) Data Aggregation

    K Number
    K212046
    Device Name
    Impertech Surgical Face Mask
    Date Cleared
    2021-11-18

    (141 days)

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

    Impertech Industries Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Impertech Surgical Face Mask are intended to be worn to protect 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 fluid. This is a single use, disposable device, provided non-sterile.
    Device Description
    The Impertech Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the user's mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of melt blown fiber. The outer facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided non-sterile.
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