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510(k) Data Aggregation

    K Number
    K220491
    Device Name
    Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
    Manufacturer
    Hainan Asther Medical Equipment Co., Ltd
    Date Cleared
    2022-05-14

    (81 days)

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

    Hainan Asther Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for medical purpose that is worn on the examination between patient and examiner. In addition, these examination gloves were tested for use with the following chemotherapy drug concentrations per ASTN D6978-05(2019): The following drugs had NO breakthrough detected up to 240 minutes: Cisplatin, 1.0 mg/ml (1,000 ppm) Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) Dacarbazine, 10.0 mg/ml (10,000 ppm) Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) Etoposide, 20.0 mg/ml (20,000 ppm) Fluorouracil, 50.0 mg/ml (50,000 ppm) Paclitaxel, 6.0 mg/ml (6,000 ppm) Please note that the following drugs have low permeation times of less than 240 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 34.4minutes ThioTepa10.0 mg/ml (10,000 ppm),88.5 minutes WARNING: Do not use with Carmustine and Thiotepa
    Device Description
    Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
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