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510(k) Data Aggregation

    K Number
    K052955
    Device Name
    NITRILE BLUE POWDERED EXAMINATION GLOVES
    Manufacturer
    GREAT GLOVE SDN BHD
    Date Cleared
    2006-01-19

    (90 days)

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

    GREAT GLOVE SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powdered Nitrile Blue Examination Gloves
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    K Number
    K052956
    Device Name
    NITRILE BLUE POWDER FREE EXAMINATION GLOVE
    Manufacturer
    GREAT GLOVE SDN BHD
    Date Cleared
    2005-12-21

    (61 days)

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

    GREAT GLOVE SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Nitrile Blue Powder Free Examination Glove
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    K Number
    K020363
    Device Name
    GREAT GLOVE LATEX EXAMINATION POWDERFREE GLOVES WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
    Manufacturer
    GREAT GLOVE SDN BHD
    Date Cleared
    2002-04-10

    (65 days)

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

    GREAT GLOVE SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Latex examination powderfree gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Not Found
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    K Number
    K993386
    Device Name
    LATEX EXAMINATION POWDERED GLOVES
    Manufacturer
    GREAT GLOVE SDN BHD
    Date Cleared
    1999-12-20

    (73 days)

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

    GREAT GLOVE SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Latex Examination powdered glove is a disposable device intended for Medical purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.
    Device Description
    Latex Examination Powdered Gloves
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