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510(k) Data Aggregation

    K Number
    K091662
    Device Name
    POWDERED VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.
    Date Cleared
    2009-07-30

    (51 days)

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

    ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06.
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    K Number
    K091663
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.
    Date Cleared
    2009-07-27

    (48 days)

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

    ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
    Ask a Question

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