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510(k) Data Aggregation

    K Number
    K030284
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
    Manufacturer
    PT. SMARTGLOVE INDONESIA
    Date Cleared
    2003-03-25

    (57 days)

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

    PT. SMARTGLOVE INDONESIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Examination Gloves (White, Blue, Purple)
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