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510(k) Data Aggregation

    K Number
    K103675
    Device Name
    CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE
    Date Cleared
    2011-10-03

    (291 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHIENMAX VIETNAM CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
    Device Description
    Chienmax Vietnam Co. Ltd Powder Free Blue Nitrile Patient Examination Gloves are Class I disposable device which are made up of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and which meets all of the requirements of ASTM standard D6319 00a (2005).
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