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510(k) Data Aggregation

    K Number
    K002218
    Device Name
    NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE
    Date Cleared
    2000-08-15

    (22 days)

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

    SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K002220
    Device Name
    NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
    Date Cleared
    2000-08-15

    (22 days)

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

    SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K002216
    Device Name
    NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE
    Date Cleared
    2000-08-11

    (18 days)

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

    SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K002217
    Device Name
    NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE
    Date Cleared
    2000-08-11

    (18 days)

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

    SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K994136
    Device Name
    POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
    Date Cleared
    2000-02-03

    (58 days)

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

    SHANGHAI CHAMPION PLASTIC PRODUCTS 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 exar iner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder-Free Non-Sterile Vinyl Examination Gloves
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    K Number
    K994036
    Device Name
    PRE-POWDERED VINYL EXAM GLOVE, NON STERILE
    Date Cleared
    1999-12-20

    (21 days)

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

    SHANGHAI CHAMPION PLASTIC PRODUCTS 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
    PRE-POWDERED NON-STERILE. VINYL EXAMINATION GLOVES
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