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510(k) Data Aggregation

    K Number
    K160562
    Device Name
    Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
    Manufacturer
    HARTALEGA SND. BHD.
    Date Cleared
    2016-10-13

    (227 days)

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

    HARTALEGA SND. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs in accordance with ASTM D6978-05, Standard Practice for Practice for Assessment of Resistance of Medical Gloves to Permeation by 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 (10.1 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 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 |
    Device Description
    Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs
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    K Number
    K112976
    Device Name
    NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM
    Manufacturer
    HARTALEGA SND. BHD.
    Date Cleared
    2012-02-02

    (119 days)

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

    HARTALEGA SND. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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