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510(k) Data Aggregation

    K Number
    K182308
    Device Name
    Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
    Manufacturer
    Sri Trang Gloves (Thailand) Co., LTD.
    Date Cleared
    2019-05-30

    (279 days)

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

    Sri Trang Gloves (Thailand) Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device has been tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: The tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/mL, 12.8 minutes breakthrough detection time Cisplatin 1.0 mg/mL, No breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, No breakthrough up to 240 minutes Dacarbazine (DTIC) 10.0 mg/mL, No breakthrough up to 240 minutes Doxorubicin Hydrochloride 2.0 mg/mL, No breakthrough up to 240 minutes Etoposide (Toposar) 20.0 mg/mL, No breakthrough up to 240 minutes Fluorouracil 50.0 mg/mL, No breakthrough up to 240 minutes Methotrexate 25 mg/mL, No breakthrough up to 240 minutes Paclitaxel (Taxol) 6.0 mg/mL, No breakthrough up to 240 minutes Thiotepa 10.0 mg/mL, 4.5 minutes breakthrough detection time Vincristine Sulfate 1.0 mg/mL, No breakthrough up to 240 minutes CAUTION: Carmustine and Thiotepa have low breakthrough times of 12.8 and 4.5 minutes respectively.
    Device Description
    Non-sterile, Powder-Free Nitrile Examination Glove, Pink, and Tested for Use with Chemotherapy Drugs
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    K Number
    K182241
    Device Name
    Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
    Manufacturer
    Sri Trang Gloves (Thailand) Co., LTD
    Date Cleared
    2019-03-11

    (203 days)

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

    Sri Trang Gloves (Thailand) Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The tested chemotherapy drugs are as follows: - Carmustine (BCNU) 3.3 mg/mL Cisplatin 1.0 mg/mL Cyclophosphamide (Cytoxan) 20 mg/mL Dacarbazine (DTIC) 10.0 mg/mL Doxorubicin Hydrochloride 2.0 mg/mL Etoposide (Toposar) 20.0 mg/mL Fluorouracil 50.0 mg/mL Methotrexate 25 mg/mL Paclitaxel (Taxol) 6.0 mg/mL Thiotepa 10.0 mg/mL Vincristine Sulfate 1.0 mg/mL Note that Carmustine(BCNU) and Thiotepa have low permeation times. Fentayl tested as follows: Fentanyl citrate 100 mcg/2mL
    Device Description
    Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs.
    Ask a Question

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