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510(k) Data Aggregation

    K Number
    K211758
    Device Name
    Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
    Manufacturer
    Hartalega Ngc Sdn. Bhd.
    Date Cleared
    2021-08-03

    (57 days)

    Product Code
    OPC, LZC
    Regulation Number
    880.6250
    Why did this record match?
    Product Code :

    OPC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a 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. These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. | Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes | |---------------------------------------|------------------------------------------------| | Carmustine (3.3 mg/ml) | 14.9 | | 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) | 22.9 | | Vincristine Sulfate (1.0 mg/ml) | >240 | Please note that Carmustine and Thiotepa have extremely low permeation times of 14.9 minutes. Warning: Do not use with Carmustine Warning: Do not use with Thiotepa
    Device Description
    Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) is a 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.
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