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510(k) Data Aggregation

    K Number
    K110185
    Device Name
    NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
    Manufacturer
    TANGSHAN BAOJIE GLOVE CO., LTD
    Date Cleared
    2011-04-04

    (73 days)

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

    TANGSHAN BAOJIE GLOVE CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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 Gloves that meets all of the requirements of ASTM standard D 6139-05
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