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510(k) Data Aggregation

    K Number
    K122176
    Device Name
    POWDERED VINYL EXAMINATION GLOVES
    Date Cleared
    2014-04-11

    (627 days)

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

    SHU TONG XINGHUA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Powdered Viny! 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
    Powdered Vinyl Examination Gloves
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    Ask a specific question about this device

    K Number
    K122377
    Device Name
    POWDER FREE VINYL EXAMINATION GLOVES
    Date Cleared
    2014-04-11

    (627 days)

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

    SHU TONG XINGHUA CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Powder Free Vinyl 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
    Powder Free Vinyl Examination Gloves
    Ask a Question

    Ask a specific question about this device

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