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510(k) Data Aggregation

    K Number
    K955556
    Device Name
    FLUID RESISTANT MASK
    Date Cleared
    1996-04-25

    (142 days)

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

    AMERICAN THRESHOLD HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
    Device Description
    The Fluid Resistant Masks are constructed of a light weight spunbonded polyolefin or cellulosic outer facing, a meltblown polyolefin filter media, and a light weight spunbonded polyolefin or cellulosic inner facing. The three layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The bodies have either light weight polyolefin or cellulosic nonwoven material sonically welded or otherwise attached to both sides of the body (ties on the surgeons tie masks) or polyolefin/elastic earloops sonically welded or otherwise attached to both sides of the body. The masks have a malleable aluminum wire encapsulated in the facing to form the mask to fit the nose.
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    K Number
    K955557
    Device Name
    FLUID REISISTANT EYESHIELD MASK
    Date Cleared
    1996-04-25

    (142 days)

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

    AMERICAN THRESHOLD HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is intended for use in infection control practices to minimize contamination caused by exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids.
    Device Description
    The Fluid Resistant Eyeshield Masks are constructed of a light weight spunbonded polyolefin or cellulosic outer facing, a meltblown polyolefin filter media, and a light weight spunbonded polyolefin or cellulosic inner facing. The three layers of the mask body are collated and sonically welded around the edges to enclose the filter media. The bodies have either light weight polyolefin or cellulosic nonwoven material sonically welded or otherwise attached to both sides of the body (ties on the surgeons tie masks) or polyolefin/elastic earloops sonically welded or otherwise attached to both sides of the body. The masks have a malleable aluminum wire encapsulated in the facing to form the mask to fit the nose. An optical quality eyeshield is attached to the mask by ultrasonic welding.
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