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510(k) Data Aggregation

    K Number
    K003563
    Device Name
    POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE
    Manufacturer
    NING BO YUJIANG RUBBER & PLASTIC CO.
    Date Cleared
    2001-01-02

    (43 days)

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

    **NING BO YUJIANG RUBBER **& PLASTIC CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991821
    Device Name
    NITRILE EXAMINATION GLOVE, POWDERED, BLUE
    Manufacturer
    NING BO YUJIANG RUBBER & PLASTIC CO.
    Date Cleared
    1999-07-01

    (35 days)

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

    **NING BO YUJIANG RUBBER **& PLASTIC CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    The device is powdered Nitrile Exam Gloves. They are non-sterile, single use, disposable gloves.
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