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510(k) Data Aggregation

    K Number
    K200915
    Device Name
    Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs
    Manufacturer
    GX Corporation Sdn Bhd
    Date Cleared
    2021-07-09

    (459 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    GX Corporation Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Powder Free White Sterilized Polyisoprene Surgical Gloves- Tested for Use with Chemotherapy Drugs is a disposable device intended for invasive surgery procedures that is to be worn on both the hands by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
    Device Description
    Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs.
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    K Number
    K183354
    Device Name
    Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    GX Corporation SDN BHD
    Date Cleared
    2019-06-20

    (199 days)

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

    GX Corporation 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 worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
    Device Description
    Powder Free Blue Nitrile Examination Gloves - Tested for Use with 32 Chemotherapy Drugs and Fentanyl Citrate
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    K Number
    K111328
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2011-07-15

    (65 days)

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

    GX CORPORATION SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This non-sterile 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 Examination Glove Coated with Cucumber (Blue & Green)
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    K Number
    K102074
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2010-11-02

    (99 days)

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

    GX CORPORATION SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This 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 Examination Gloves, Tested For Use With Chemotherapy Drugs, Blue (SG).
    Ask a Question
    K Number
    K101828
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2010-10-04

    (95 days)

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

    GX CORPORATION SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This 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 Latex Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue).
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    K Number
    K093759
    Device Name
    MULTIPLE NAME MODEL MULTIPLE
    Manufacturer
    GX CORPORATION SDN BHD (PLANT 1)
    Date Cleared
    2010-02-19

    (74 days)

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

    GX CORPORATION SDN BHD (PLANT 1)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This 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 Examination Gloves, Bubble Gum Scented, Blue
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    K Number
    K091851
    Device Name
    STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2009-12-28

    (189 days)

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

    GX CORPORATION SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This 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
    Sterile, Powder Free Nitrile Examination Gloves, Blue Tested For Use With Chemotherapy Drugs.
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    K Number
    K092072
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2009-11-04

    (119 days)

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

    GX CORPORATION SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This 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 Examination Gloves, Grape Scented, Blue
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    K Number
    K091643
    Device Name
    POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2009-11-02

    (151 days)

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

    GX CORPORATION SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This 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 is tested for use with Dacarbazine (DTIC), Cyclophosphamide (Cytoxan), Doxorubicin Hydrochloride, 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol) Warning: Not Recommended For Use With Carmustine and Thio-Tepa
    Device Description
    Powder Free Latex Examination Gloves, Blue Tested For Use With Chemotherapy Drugs
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    K Number
    K092200
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, ORANGE (ORANGE SCENTED), WHITE (VANILLA SCENTED)
    Manufacturer
    GX CORPORATION SDN BHD
    Date Cleared
    2009-09-16

    (56 days)

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

    GX CORPORATION SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This 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 Examination Gloves, Orange Scented, Orange Powder Free Nitrile Examination Gloves, Vanilla Scented, White
    Ask a Question

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