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510(k) Data Aggregation

    K Number
    K091429
    Device Name
    VINYL POWDER FREE EXAMINATION GLOVE
    Date Cleared
    2009-07-22

    (70 days)

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

    SHUN DA (XINGHUA) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination Vinyl Powder Free Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Vinyl Powder Free Examination Glove
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    K Number
    K091427
    Device Name
    VINYL POWDERED EXAMINATION GLOVE
    Date Cleared
    2009-06-23

    (41 days)

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

    SHUN DA (XINGHUA) CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

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