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510(k) Data Aggregation

    K Number
    K220545
    Device Name
    Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
    Manufacturer
    HL Rubber Industries Sdn bhd
    Date Cleared
    2022-05-26

    (90 days)

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

    HL Rubber Industries Sdn bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05, Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 23.4 minute and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 77.5 minute. Warning statements has been included. WARNING: DO NOT USE WITH CARMUSTINE WARNING: DO NOT USE WITH THIOTEPA
    Device Description
    Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs
    Ask a Question
    K Number
    K141021
    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
    Manufacturer
    HL RUBBER INDUSTRIES SDN BHD
    Date Cleared
    2014-08-26

    (127 days)

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

    HL RUBBER INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free 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 Examination Gloves, Orange Color
    Ask a Question
    K Number
    K140316
    Device Name
    EXAMINATION GLOVES
    Manufacturer
    HL RUBBER INDUSTRIES SDN BHD
    Date Cleared
    2014-07-11

    (151 days)

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

    HL RUBBER INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free 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
    Not Found
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    K Number
    K130038
    Device Name
    POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE
    Manufacturer
    HL RUBBER INDUSTRIES SDN BHD
    Date Cleared
    2013-02-21

    (45 days)

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

    HL RUBBER INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05. Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs
    Ask a Question
    K Number
    K100369
    Device Name
    POWDER-FREE NITRILE GLOVES, BLACK
    Manufacturer
    HL RUBBER INDUSTRIES SDN BHD
    Date Cleared
    2010-05-20

    (97 days)

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

    HL RUBBER INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free 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 GLOVES, BLACK
    Ask a Question
    K Number
    K063522
    Device Name
    POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)
    Manufacturer
    HL RUBBER INDUSTRIES SDN BHD
    Date Cleared
    2007-02-08

    (78 days)

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

    HL RUBBER INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination betwen patient and examiner.
    Device Description
    Powdered Patient Nitrile Examination Gloves (White / Blue color)
    Ask a Question
    K Number
    K063524
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)
    Manufacturer
    HL RUBBER INDUSTRIES SDN BHD
    Date Cleared
    2007-01-23

    (62 days)

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

    HL RUBBER INDUSTRIES SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner hands or fingers to prevent contamination between patient and examiner.
    Device Description
    Powder - Free Nitrile White and Blue Examination Gloves
    Ask a Question

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