Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K223748
    Device Name
    Nitrile Exam Gloves (Chemotherapy Drug Tested)
    Date Cleared
    2023-01-13

    (30 days)

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

    US Medical Glove Company LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A powder-free, nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: | Drug Name | Concentration Tested | Minimum Breakthrough Detection Time (Minutes) | |----------------------------|-------------------------|-----------------------------------------------| | Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | No breakthrough up to 240 | | Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | No breakthrough up to 240 | | Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | No breakthrough up to 240 | | Fluorouracil | 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 | | Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | No breakthrough up to 240 | | Cisplatin | 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 | | Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | No breakthrough up to 240 | | Ifosfamide | 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 | | Mitoxantrone | 2.0 mg/ml (2,000 ppm) | No breakthrough up to 240 | | Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 | | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | No breakthrough up to 14.3 * | | Thiotepa | 10.0 mg/ml (10,000 ppm) | No breakthrough up to 48.2 * | *Please note that Carmustine and Thiotepa have low permeation times. Do not use with Carmustine and/or Thiotepa.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1