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510(k) Data Aggregation

    K Number
    K201531
    Device Name
    Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
    Manufacturer
    Hartalega SDN. BHD.
    Date Cleared
    2020-08-05

    (58 days)

    Product Code
    LZA, LZC, QDO
    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 Sterile NItrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a 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 and Fentanyl Citrate. The gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
    Device Description
    Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
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    K Number
    K200897
    Device Name
    Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
    Manufacturer
    Hartalega SDN. BHD.
    Date Cleared
    2020-06-01

    (59 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
    The Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs. The Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminations. It is also tested for use against Chemotherapy Drugs.
    Device Description
    Not Found
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    K Number
    K180786
    Device Name
    Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
    Manufacturer
    HARTALEGA SDN. BHD.
    Date Cleared
    2018-11-02

    (221 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 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Violet Blue (VBLU)-Extended Cuff is a 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 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs - Aqua Blue (ABLU) is a 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.
    Device Description
    Not Found
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    K Number
    K173509
    Device Name
    Biodegradable Nitrile Powder Free Examination Glove (Blue)
    Manufacturer
    Hartalega Sdn. Bhd.
    Date Cleared
    2018-08-17

    (277 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 Biodegradable Nitrile Powder Free Examination Glove (Blue) is a non-sterile disposable device intended for medical purpose that is worn on examinet's hand to prevent contamination between patient and examiner.
    Device Description
    Biodegradable Nitrile Powder Free Examination Glove (Blue)
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    K Number
    K180505
    Device Name
    Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
    Manufacturer
    Hartalega Sdn. Bhd.
    Date Cleared
    2018-06-14

    (108 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 Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White) 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. Is it 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) 17.2 minutes Cisplatin (1.0 mg/ml) >240 minutes Cyclophosphamide (20 mg/ml) > 240 minutes Dacarbazine (10.0 mg/ml) >240 minutes Doxorubicin Hydrochloride (2.0 mg/ml) > 240 minutes Etoposide (20 mg/ml) > 240 minutes Fluorouracil (50 mg/ml) > 240 minutes Methotrexate (25 mg/ml) > 240 minutes Mitomycin C (0.5 mg/ml) > 240 minutes Paclitaxel (6.0 mg/ml) > 240 minutes Thiotepa (10.0 mg/ml) 36.1 minutes Vincristine Sulfate (1.0 mg/ml) >240 minutes Do not use with Carmustine. Do not use with Thiotepa.
    Device Description
    Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (White)
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    K Number
    K173137
    Device Name
    Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
    Manufacturer
    Hartalega Sdn. Bhd.
    Date Cleared
    2017-12-12

    (74 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 Glove Tested for Use with Chemotherapy Drugs (Pink) 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. Is it also tested to be used against Chemotherapy Drugs.
    Device Description
    Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
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    K Number
    K171874
    Device Name
    Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
    Manufacturer
    HARTALEGA SDN. BHD.
    Date Cleared
    2017-10-12

    (111 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 Colloidal Oatmeal USP Skin Protectant and Tested for Use with Chemotherapy Drugs (Dawn 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. It is also tested to be used against Chemotherapy Drugs.
    Device Description
    Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use with Chemotherapy Drugs (Dawn Blue)
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    K Number
    K162491
    Device Name
    Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
    Manufacturer
    HARTALEGA SDN. BHD.
    Date Cleared
    2017-02-08

    (154 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 Low Dermatitis Potential Claim (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 with Low Dermatitis Potential Claim (Blue)
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    K Number
    K162818
    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
    2017-01-09

    (95 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 Potential 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 Dermatitis Potential Claim and Tested for Use with Chemotherapy Druzs (Blue)
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    K Number
    K162819
    Device Name
    Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
    Manufacturer
    HARTALEGA SDN. BHD.
    Date Cleared
    2017-01-09

    (95 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 Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs 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) 10.1 minutes Cisplatin (1.0 mg/ml) > 240 minutes Cyclophosphamide (20 mg/ml) > 240 minutes Dacarbazine (10.0 mg/ml) > 240 minutes Doxorubicin Hydrochloride (2.0mg/ml) > 240 minutes Etoposide (20.0 mg/ml) > 240 minutes Fluorouracil (50.0 mg/ml) > 240 minutes Methotrexate (25 mg/ml) > 240 minutes Mitomycin C (0.5 mg/ml) > 240 minutes Paclitaxel (6.0 mg/ml) > 240 minutes Thiotepa (10.0 mg/ml) 30.4 minutes Vincristine Sulfate (1.0 mg/ml) > 240 minutes Please note that Carmustine and Thiotepa have extremely low permeation times of 10.1 minutes.
    Device Description
    Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
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