BEUDAMED
    FDA Registration Active 🇨🇳 China

    TRUE GLOVE FACTORY

    Reg #: 3009055041 · FEI: 3009055041 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    TRUE GLOVE FACTORY
    Registration Number
    3009055041
    FEI Number
    3009055041
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    NO.6-1 East XingAn Road, Linqu
    City
    Weifang Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K233182

    Owner / Operator

    Firm Name
    TRUE GLOVE FACTORY
    Operator Number
    10036844
    Address
    NO.6-1 East Xing'an Road, Linqu
    City
    Weifang
    State
    Shandong
    Postal Code
    262600
    Country
    CN
    Correspondent
    Jianbo Shi

    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
    Vinyl Patient Examination Glove LYZ
    Latex Patient Examination Glove LYY
    Medical Glove, Specialty LZC

    Proprietary Names

    Multiple

    Establishment Types

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