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510(k) Data Aggregation

    K Number
    K203528
    Device Name
    KNH Surgical Face Mask
    Date Cleared
    2022-11-16

    (714 days)

    Product Code
    Regulation Number
    878.4040
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    Applicant Name (Manufacturer) :

    KNH Surgical Face Mask

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KNH Surgical Face Mask is intended to protect both patient and healthcare workers from the transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only. Models: 1MMAB50DM2 (Level 1), 1MMAB50DM3 (Level 2)
    Device Description
    The KNH Surgical Face Masks are four-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single-use only. The mask is constructed of nonwoven fabric, including the outer cover web, insertion, filter web and the inner cover web, the mask is provided with ear loops and a nose wire for individualized fit. The models 1MMAB50DM2 and 1MMAB50DN3 differ in the thickness of the filter web layer.
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