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510(k) Data Aggregation

    K Number
    K974151
    Device Name
    VINYL PATIENT EXAMINATION GLOVES (POWDERED)
    Manufacturer
    SHANGHAI SUPER GLOVES CO., LTD.
    Date Cleared
    1997-12-18

    (44 days)

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

    SHANGHAI SUPER GLOVES CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A glove is worn on the hand of healthcare personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. A 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
    Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.
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    K Number
    K974120
    Device Name
    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
    Manufacturer
    SHANGHAI SUPER GLOVES CO., LTD.
    Date Cleared
    1997-12-17

    (47 days)

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

    SHANGHAI SUPER GLOVES CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. A 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
    Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.
    Ask a Question

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