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510(k) Data Aggregation

    K Number
    K081970
    Device Name
    BIOCLEAN CHEMO SHIELD
    Manufacturer
    NITRITEX (M) SDN. BHD.
    Date Cleared
    2009-03-11

    (244 days)

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

    NITRITEX (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. Tested for use with Chemotherapy Drugs
    Device Description
    The BioClean Chemo Shield is a powder free, sterile, Polychloroprene examination glove, tested for use with chemotherapy agents.
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    K Number
    K081971
    Device Name
    BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES
    Manufacturer
    NITRITEX (M) SDN. BHD.
    Date Cleared
    2008-12-23

    (166 days)

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

    NITRITEX (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. Tested for use with Chemotherapy Drugs
    Device Description
    The BioClean Chemo Ultimate is a powder free, sterile, Polychloroprene examination glove, tested for use with chemotherapy agents.
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    K Number
    K081972
    Device Name
    BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    NITRITEX (M) SDN. BHD.
    Date Cleared
    2008-12-11

    (154 days)

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

    NITRITEX (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. Tested for use with the following Chemotherapy Drugs: Cisplatinum, Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide, 5-Flourouracil, Methotrexate & Paciitaxel.
    Device Description
    BioClean Chemo Emerald Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs (Sterile)
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