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510(k) Data Aggregation

    K Number
    K032907
    Device Name
    FUGUAN (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2003-11-20

    (64 days)

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

    SHIJIAZHUANG FUGUAN 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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064
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    K Number
    K032908
    Device Name
    FUGUAN (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHIJIAZHUANG FUGUAN PLASTIC PRODUCTS CO., LTD.
    Date Cleared
    2003-11-20

    (64 days)

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

    SHIJIAZHUANG FUGUAN 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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00e4
    Ask a Question

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