BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHANDONG HUAYUE GLOVE CO., LTD.

    Reg #: 3007707004 · FEI: 3007707004 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SHANDONG HUAYUE GLOVE CO., LTD.
    Registration Number
    3007707004
    FEI Number
    3007707004
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    East of Yifan Rd. and North of Naqi Rd., Science and Technology Based Ind. Zone
    City
    Zibo Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K222074

    Owner / Operator

    Firm Name
    Shandong Huayue Glove Co., Ltd.
    Operator Number
    10029444
    Address
    East of Yifan Rd. and North of Naqi Rd., Science and Technology Based Ind. Zone
    City
    Zibo
    State
    Shandong
    Postal Code
    255400
    Country
    CN
    Correspondent
    Jinyou Lin

    US Agent

    Business Name
    Omni International Corp
    Contact Name
    Ken Li
    Address
    35 Constitution Dr Ste 1D
    City
    Bedford
    State
    NH
    ZIP
    03110
    Country
    US
    Email
    [email protected]
    Phone
    603 4711499

    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