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510(k) Data Aggregation

    K Number
    K221718
    Device Name
    Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural)
    Manufacturer
    Hartalega NGC SDN BHD
    Date Cleared
    2022-09-24

    (103 days)

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

    Hartalega NGC SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs. The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | |---------------------------------------|------------------------------------------------| | Carmustine (3.3 mg/ml) | 12.3 | | Cisplatin (1.0 mg/ml) | >240 | | Cyclophosphamide (20.0 mg/ml) | >240 | | Dacarbazine (10.0 mg/ml) | >240 | | Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | | Etoposide (20.0 mg/ml) | >240 | | Fluorouracil (50.0 mg/ml) | >240 | | Methotrexate (25.0 mg/ml) | >240 | | Mitomycin C (0.5 mg/ml) | >240 | | Paclitaxel (6.0 mg/ml) | >240 | | Thiotepa (10.0 mg/ml) | 17.4 | | Vincristine Sulfate (1.0 mg/ml) | >240 | Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively. Warning: Do not use with Carmustine and Thiotepa
    Device Description
    Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from synthetic polyisoprene latex.
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    K Number
    K151997
    Device Name
    Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
    Manufacturer
    HARTALEGA NGC SDN BHD
    Date Cleared
    2016-03-31

    (255 days)

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

    HARTALEGA NGC SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU) is nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs.
    Device Description
    Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs -Violet Blue (VBLU)
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    K Number
    K151836
    Device Name
    NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
    Manufacturer
    HARTALEGA NGC SDN BHD
    Date Cleared
    2015-10-21

    (107 days)

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

    HARTALEGA NGC SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free Examination Gloves is a non - sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Not Found
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    K Number
    K151343
    Device Name
    Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
    Manufacturer
    HARTALEGA NGC SDN BHD
    Date Cleared
    2015-08-24

    (97 days)

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

    HARTALEGA NGC SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White) is non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner. It is also tested to be used against Chemotherapy Drugs.
    Device Description
    Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White)
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