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510(k) Data Aggregation

    K Number
    K041041
    Device Name
    NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
    Date Cleared
    2004-06-08

    (47 days)

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

    SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and evan miner.
    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 D5250-00 Ed
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    K Number
    K032071
    Device Name
    POWDER FREE VINYL EXAMINATION GLOVE
    Date Cleared
    2003-10-10

    (99 days)

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

    SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiners 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 380,6250. Powder free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00 E4
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    K Number
    K971415
    Device Name
    VINYL PATIENT EXAMINATION GLOVE, POWDER-FREE
    Date Cleared
    1997-05-23

    (36 days)

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

    SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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, Powder-free, 80L YZ, conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.
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    K Number
    K971423
    Device Name
    VINYL PATIENT EXAMINATION GLOVE, POWDERED
    Date Cleared
    1997-05-23

    (36 days)

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

    SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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, CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, powdered with an absorbable dusting starch powder, USP, Class III and conform to all requirements of ASTM Standard D5250-92 and FDA 1000 ml water leak test.
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