BEUDAMED
    FDA Registration Active 🇨🇳 China

    Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs

    Reg #: 9615978 · FEI: 3003045222 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Registration Number
    9615978
    FEI Number
    3003045222
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 369, JIASONG ZHONG ROAD, HUAXIN, QINGPU
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K220155

    Owner / Operator

    Firm Name
    SHANGHAI MOTEX HEALTHCARE CO., LTD.
    Operator Number
    9041164
    Address
    NO. 369, JIASONG ZHONG ROAD, HUAXIN, QINGPU
    City
    SHANGHAI
    State
    CN-SH
    Postal Code
    201708
    Country
    CN

    US Agent

    Business Name
    ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
    Contact Name
    SHU-CHEN CHENG
    Address
    2064 TAMARIN DR.
    City
    COLUMBUS
    State
    OH
    ZIP
    43235
    Country
    US
    Email
    [email protected]
    Phone
    614 5888168

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA
    Medical Glove, Specialty LZC

    Proprietary Names

    Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device