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510(k) Data Aggregation

    K Number
    K030529
    Device Name
    LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
    Manufacturer
    JDA (TIANJIN) PLASTIC RUBBER CO., LTD.
    Date Cleared
    2003-08-08

    (170 days)

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

    JDA (TIANJIN) PLASTIC RUBBER CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nitrile powder-free 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
    Nitrile powder-free patient examination, that meets all of the requirements of ASTM standard D 6319-00ae3.
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