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510(k) Data Aggregation

    K Number
    K201748
    Device Name
    Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
    Manufacturer
    Hartalega SDN BHD
    Date Cleared
    2020-10-02

    (98 days)

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

    Hartalega SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs. These gloves were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination.
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    K Number
    K180645
    Device Name
    Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
    Manufacturer
    Hartalega Sdn Bhd
    Date Cleared
    2018-11-16

    (249 days)

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

    Hartalega Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs -(Lemon Green) is a non-sterile 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. The list of Chemotherapy Drugs tested (with breakthrough times) is as below: Carmustine (3.3 mg/ml) 5.4 minutes Cisplatin (1.0 mg/ml) > 240 minutes Cyclophosphamide (20.0 mg/ml) > 240 minutes Dacarbazine (10.0 mg/ml) > 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes Etoposide (20.0 mg/ml) > 240 minutes Fluorouracil (50.0 mg/ml) > 240 minutes Methotrexate (25.0 mg/ml) > 240 minutes Mitomycin C (0.5 mg/ml) > 240 minutes Paclitaxe 1 (6.0 mg/ml) > 240 minutes Thiotepa (10.0 mg/ml) 35.2 minutes Vincristine Sulfate (1.0 mg/ml) > 240 minutes Please note that Carmustine and Thiotepa have extremely low permeation times of 5.4 minutes
    Device Description
    Not Found
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    K Number
    K180644
    Device Name
    Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
    Manufacturer
    Hartalega Sdn Bhd
    Date Cleared
    2018-08-10

    (151 days)

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

    Hartalega Sdn Bhd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free Examination Glove with Colloidal Oatmeal - Lemon Green is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Nitrile Powder Free Examination Glove with Colloidal Oatmeal - Lemon Green
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    K Number
    K170152
    Device Name
    POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2017-05-05

    (108 days)

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

    HARTALEGA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polychloroprene Powder Free Surgical Glove (Green) is made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    Polychloroprene Powder Free Surgical Glove (Green) is made of synthetic rubber.
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    K Number
    K160560
    Device Name
    Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2016-08-04

    (157 days)

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

    HARTALEGA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nittile Powder Free Examination Glove with Low Dermatitis Claim and Tested for Use with Chemotherapy Drugs (Blue) is a non- sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs (tested with breakthrough times) as per attached table.
    Device Description
    Nitrile Powder Free Examination Glove with Low Dernatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
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    K Number
    K150593
    Device Name
    Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2015-06-09

    (92 days)

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

    HARTALEGA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examination between patient and examiner
    Device Description
    Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
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    K Number
    K150103
    Device Name
    Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2015-04-23

    (93 days)

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

    HARTALEGA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs is a non-sterile disposable device intended for medical and dental purpose that is wor on the examiners hand to prevent contraniation total weather and examiner. It is also tested to be assess of the list of Chemotherapy Drugs tested (with breakthrough times) as per attached table. Please note that Carmustine and Thiotepa have externely low permeation times of 45.4 minutes and 30.9 minutes, respectively.
    Device Description
    Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs
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    K Number
    K142588
    Device Name
    Nitrile Powder Free Examination Glove (Blue)
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2014-12-18

    (94 days)

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

    HARTALEGA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free Examination Glove (Blue) is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner
    Device Description
    Nitrile Powder Free Examination Glove (Blue)
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    K Number
    K140050
    Device Name
    NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2014-09-12

    (246 days)

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

    HARTALEGA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination betwreen patient and examiner. The Nittile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (DKBU) and Nitrile Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant - Blue (Dawn Blue)
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    K Number
    K133953
    Device Name
    LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
    Manufacturer
    HARTALEGA SDN BHD
    Date Cleared
    2014-05-28

    (156 days)

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

    HARTALEGA SDN BHD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove - Lemon Green (Lavender Scent) 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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