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510(k) Data Aggregation

    K Number
    K182554
    Device Name
    Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs
    Date Cleared
    2019-03-22

    (186 days)

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

    **He Chuang Plastic **& Rubber Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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. The proposed device was tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The following chemicals have been tested with proposed device. | Test Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes | |----------------------------|------------------------|----------------------------------------| | *Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 15.1 | | Cisplatin | 1.0 mg/ml(1,000 ppm) | >240 | | Dacarbazine(DTIC) | 10.0 mg/ml (10,000ppm) | >240 | | Cyclophosphamide (Cytoxan) | 20 mg/ml(20,000 ppm) | >240 | | Doxorubicin Hydrochloride | 2.0 mg/ml(2,000 ppm) | >240 | | Etoposide (Toposar) | 20.0 mg/ml(20,000 ppm) | >240 | | Fluorouracil | 50.0 mg/ml(50,000 ppm) | >240 | | Mechlorethamine HCl | 1.0 mg/ml(1,000 ppm) | >240 | | Methotrexate | 25.0 mg/ml(25,000 ppm) | >240 | | Mitomycin C | 0.5 mg/ml(500 ppm) | >240 | | Paclitaxel (Taxol) | 6.0 mg/ml(6,000 ppm) | >240 | | *Thiotepa | 10.0 mg/ml(10,000 ppm) | 15.1 | | Vincristine Sulfate | 1.0 mg/ml(1,000 ppm) | >240 |
    Device Description
    The Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs 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.
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