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510(k) Data Aggregation

    K Number
    K101163
    Device Name
    BIOGEL ORTHOPRO INDICATOR UNDERGLOVE
    Date Cleared
    2010-11-23

    (211 days)

    Product Code
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOLNLYCKE HEALTH CARE USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Biogel® OrthoPro® Indicator® Underglove is a disposable device made of natural rubber latex that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
    Device Description
    The proposed device, the Biogel® OrthoPro® Indicator® Underglove is manufactured of natural rubber latex. The Biogel® OrthoPro® Indicator® Underglove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device(s) that have been legally marketed by Mölnlycke Health Care for many years. The glove former design used in the manufacture of this glove allows the Biogel® OrthoPro® Indicator Underglove to provide the user with these additional features: - . Slightly Curved Former with Independent/Displaced thumb - Improved Fit, Feel and Comfort (compared to the current Biogel" Orthopaedic Surgical Glove)
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