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510(k) Data Aggregation

    K Number
    K213325
    Device Name
    Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
    Manufacturer
    Anhui Xinyisheng Medical Technology Co., Ltd
    Date Cleared
    2022-01-28

    (115 days)

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

    Anhui Xinyisheng Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with the following chemotherapy drug concentrations per ASTM 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 drug has low permeation times of less than 60 minutes: Carmustine (BCNU) 3.3 mg/ml (3.300 ppm), 23.9minutes; ThioTepa10.0 mg/ml (10,000 ppm),25.3 minutes. WARNING: Do not use Carmustine and Thiotepa
    Device Description
    Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
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