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510(k) Data Aggregation

    K Number
    K123749
    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
    Manufacturer
    KOSSAN LATEX INDUSTRIES(M)SDN BHD
    Date Cleared
    2013-03-01

    (85 days)

    Product Code
    LZA
    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 Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
    Device Description
    Powder Free Nitrile Patient Examination Glove, Green, Non-Sterile, Low Dermatitis Potential and Chemotherapy Drugs Protection Labeling Claim, meets all of the requirements of ASTM D 6319-10.
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    K Number
    K120066
    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
    Manufacturer
    KOSSAN LATEX INDUSTRIES(M)SDN BHD
    Date Cleared
    2012-11-16

    (312 days)

    Product Code
    LZA
    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 Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Patient Examination Glove, Blue, White and Green Colored, Non-Sterile, Low Dermatitis Potential Labeling Claim, meets all of the requirements of ASTM D 6319-10.
    Ask a Question
    K Number
    K111772
    Device Name
    POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE
    Manufacturer
    KOSSAN LATEX INDUSTRIES(M)SDN BHD
    Date Cleared
    2011-10-20

    (119 days)

    Product Code
    LZA
    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 Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Powder Free Nitrile Patient Examination Glove, Blue Colored, and White (Non Colored). Non-Sterile, meets all of the requirements of ASTM D 6319-10.
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    K Number
    K062764
    Device Name
    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED
    Manufacturer
    KOSSAN LATEX INDUSTRIES(M)SDN BHD
    Date Cleared
    2007-02-27

    (165 days)

    Product Code
    LZC, LZA
    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 Authorized
    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 pariesoo and examiner. This device is not intended to be used as a chemical barrier.
    Device Description
    Powder-free Nitrile Patient Examination Glove, White (non-colored) and Blue Colored, Tested for use with Chemotherapy Drugs
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