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510(k) Data Aggregation

    K Number
    K220353
    Device Name
    Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
    Manufacturer
    Niujian Technology Co., Ltd
    Date Cleared
    2022-03-31

    (51 days)

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

    Niujian 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 examination 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) >240 min. Cyclophosphamide (Cytoxan),20.0 mg/ml (20,000 ppm) >240 min. Dacarbazine,10.0 mg/ml (10,000 ppm) >240 min. Doxorubicin HCI, 2.0 mg/ml (2,000 ppm) >240 min. Etoposide, 20.0 mg/ml (20,000 ppm) >240 min. Fluorouracil,50.0 mg/ml (50,000 ppm) >240 min. Paclitaxel,6.0 mg/ml (6,000 ppm) >240 min. Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7 min. ThioTepa10.0 mg/ml (10,000 ppm), 56.9 min Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 38.7minutes ThioTepa10.0 mg/ml (10.000 ppm),56.9 minutes WARNING: Do not use Carmustine and Thiotepa
    Device Description
    Not Found
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    K Number
    K220354
    Device Name
    Disposable Medical Synthetic Nitrile Examination Gloves
    Manufacturer
    Niujian Technology Co., Ltd
    Date Cleared
    2022-03-24

    (44 days)

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

    Niujian Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Medical Synthetic Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
    Device Description
    Disposable Medical Synthetic Nitrile Examination Gloves
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    K Number
    K210706
    Device Name
    Nitrile Examination Gloves
    Manufacturer
    Niujian Technology Co., Ltd.
    Date Cleared
    2021-10-19

    (223 days)

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

    Niujian Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nitrile Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
    Device Description
    Nitrile Examination Gloves are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirements specifications for barrier protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. The subject device is powder free nitrile examination gloves. The subject device is in blue color.
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