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510(k) Data Aggregation

    K Number
    K131341
    Device Name
    POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
    Date Cleared
    2014-02-06

    (273 days)

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

    SHIJIAZHUANG WINFUL PLASTIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powder Free Yellow Synthetic Vinyl Patient Examination Gloves 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
    Powder Free Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
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    K Number
    K043475
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
    Date Cleared
    2005-02-01

    (47 days)

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

    SHIJIAZHUANG WINFUL PLASTIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This powder free vinyl 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
    powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4.
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    K Number
    K043477
    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
    Date Cleared
    2005-01-07

    (22 days)

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

    SHIJIAZHUANG WINFUL PLASTIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Powdered vinyl 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
    powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4
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    Ask a specific question about this device

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