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510(k) Data Aggregation

    K Number
    K110146
    Device Name
    NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
    Manufacturer
    TANGSHAN KAIYUE GLOVE CO., LTD.
    Date Cleared
    2011-05-13

    (115 days)

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

    TANGSHAN KAIYUE GLOVE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) is a non-sterile 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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