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510(k) Data Aggregation

    K Number
    K062965
    Device Name
    CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
    Date Cleared
    2006-12-22

    (84 days)

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

    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

    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
    Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove, with extractable protein content labeling claim (50 microgram per gram of glove or less)
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    K Number
    K060775
    Device Name
    POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF
    Date Cleared
    2006-05-16

    (55 days)

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

    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

    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
    Powder-free Latex Patient Examination Glove. with extractable protein content labelling claim (50 microgram per gram of glove or less)
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    K Number
    K060771
    Device Name
    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED
    Date Cleared
    2006-05-01

    (40 days)

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

    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

    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
    Powder-Free Nitrile Patient Examination Gove, White (non-colored) and Blue Colored
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    K Number
    K024025
    Device Name
    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, VIOLET COLOR
    Date Cleared
    2002-12-18

    (12 days)

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

    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

    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
    Powder-free Nitrile Patient Examination Glove, Violet Color.
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    K Number
    K001557
    Device Name
    LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
    Date Cleared
    2000-06-09

    (21 days)

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

    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K001190
    Device Name
    POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE
    Date Cleared
    2000-05-23

    (41 days)

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

    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K992496
    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
    Date Cleared
    1999-08-25

    (30 days)

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

    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

    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
    Powder-free Nitrile Patient Examination Glove BLUE AND WHITE
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    K Number
    K992497
    Device Name
    POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
    Date Cleared
    1999-08-25

    (30 days)

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

    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

    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 Nitrile Patient Examination Glove. BLUE AND WHITE (NON-GLORED)
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    K Number
    K984019
    Device Name
    POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS)
    Date Cleared
    1998-12-23

    (41 days)

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

    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

    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
    Powder-free, Latex Patient Examination Glove with protein content labelling claim (50 ug/g glove or less).
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    K Number
    K984020
    Device Name
    POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
    Date Cleared
    1998-12-23

    (41 days)

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

    KOSSAN LATEX INDUSTRIES (M) SDN. BHD.

    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
    Powdered Latex Patient Examination Glove with protein content labeling claim (150 µg/g glove or less)
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