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510(k) Data Aggregation

    K Number
    K110247
    Device Name
    POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
    Date Cleared
    2011-06-10

    (133 days)

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

    **JIANGSU DONGLING PLASTIC **& RUBBER CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Nitrile Patient Examination Gloves,Blue Color 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
    Powder Free Nitrile Patient Examination Gloves,Blue Color are disposable device which made of nitrile synthetic rubber , intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 6319 00a (2005)e1.
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    K Number
    K110248
    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR
    Date Cleared
    2011-06-10

    (133 days)

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

    **JIANGSU DONGLING PLASTIC **& RUBBER CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Powder Free Nitrile Patient Examination Gloves, White Color 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
    Powder Free Nitrile Patient Examination Gloves, White Color are made of synthetic rubber, intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device meets all of the requirements of ASTM standard D 6319 00a (2005)e1.
    Ask a Question

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