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510(k) Data Aggregation

    K Number
    K141085
    Device Name
    WestTec Procedure Facemask;WestTec Surgical Facemask
    Manufacturer
    Date Cleared
    2015-03-27

    (333 days)

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

    WESTTEC, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    West Tec Procedure and Surgical facemasks are intended to be worn by healthcare workers to protect the user and patient against transfer of microorganisms, blood and body fluids, and airborne particulates. The WestTec Procedure and Surgical facemasks are single use, disposable devices provided non-sterile.
    Device Description
    The WestTec Procedure and Surgical facemasks are identical with the exception that the Surgical Mask has a Comfort Band to keep the inner layer away from the user's mouth to provide space between the users face and the mask making it more comfortable to wear. Both facemasks are manufactured with three layers of nonwoven polypropylene materials. The facemasks are held in place over the user's mouth and nose by two elastic ear loops welded to each facemask. The elastic ear loops are not made with natural rubber latex. The facemasks have a malleable Nose Band contained in the layers of the facemask to allow the user to fit the facemask around their nose. The facemasks are sold non-sterile and are intended to be a single use, disposable device.
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