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510(k) Data Aggregation

    K Number
    K220944
    Device Name
    PointCore Surgical Mask
    Manufacturer
    Date Cleared
    2022-09-09

    (162 days)

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

    PointCore, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PointCore Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical 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 provided nonsterile.
    Device Description
    The PointCore Surgical Mask is a surgical mask with ear loops and nose piece for fitting and securing the mask to the to the user's face. The ASTM Level of the subject device is ASTM Level 2. The finished size of the mask is 175mm x 95 mm. The masks are comprised of three layers: an outer polyethylene/polyester layer, a meltblown nonwoven filter layer, and an inner polypropylene layer. The mask also includes an adjustable nose strip and flat or round elastic ear loop. The nosepiece is manufactured from a reinforced plastic piece with a metal insert.
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