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    K Number
    K994124
    Device Name
    NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    MAPA PROFESSIONAL
    Date Cleared
    2000-08-11

    (248 days)

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

    MAPA PROFESSIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Classified by FDA's general and Plastic device Panel as Class I (21 CFR 880.6250), NIPROTECT Powder-free Nitrile Ambidextrous Gloves (80LZA). Meets all requirements of ASTM D6319 Standard for Nitrile Examination gloves for medical application.
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