BEUDAMED
    FDA Registration Active 🇨🇳 China

    ALCATRON GLOVES FACTORY

    Reg #: 3009496643 · FEI: 3009496643 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ALCATRON GLOVES FACTORY
    Registration Number
    3009496643
    FEI Number
    3009496643
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot 10, Xingan Road East, Linqu
    City
    Weifang Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K222074

    Owner / Operator

    Firm Name
    ALCATRON GLOVES FACTORY
    Operator Number
    10038885
    Address
    Lot 10, Xing'an Road East, Linqu
    City
    Weifang
    State
    Shandong
    Postal Code
    262600
    Country
    CN
    Correspondent
    Yanmei Wang

    US Agent

    Business Name
    Omni International Corp.
    Contact Name
    Renee Rees
    Address
    35 Constitution Drive, Suite 1D
    City
    Bedford
    State
    NH
    ZIP
    03110
    Country
    US
    Email
    [email protected]
    Phone
    603 4711499 ext. 201

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA
    Latex Patient Examination Glove LYY

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility