BEUDAMED
    FDA Registration Active 🇨🇳 China

    XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO LTD.

    Reg #: 3028162329 · FEI: 3028162329 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO LTD.
    Registration Number
    3028162329
    FEI Number
    3028162329
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    41 Shuangshan Road, Boshan District
    City
    Zibo Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232252

    Owner / Operator

    Firm Name
    Xinwei (Shandong) Plastic and Rubber Products Co Ltd.
    Operator Number
    10088635
    Address
    41 Shuangshan Road, Boshan District
    City
    Zibo
    State
    Shandong
    Postal Code
    255000
    Country
    CN
    Correspondent
    MAX LI

    US Agent

    Business Name
    BASIC MEDICAL TECHNOLOGY INC.
    Contact Name
    Max lee
    Address
    5300 Concours
    City
    Ontario
    State
    CA
    ZIP
    91764
    Country
    US
    Email
    [email protected]
    Phone
    909 9801678

    Products

    Device Name Product Code
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Medical Glove, Specialty LZC
    Fentanyl And Other Opioid Protection Glove QDO
    Polymer Patient Examination Glove LZA

    Proprietary Names

    Synthetic Nitrile Patient Examination Gloves, Powder Free, and Tested for Use with Chemotherapy Drugs Patient Nitrile Examination Gloves, Powder Free, Non-Sterile Synthetic Nitrile Patient Exam Gloves, Powder Free, Tested for Use w/Chemotherapy Drug Powder Free Nitrile Examination Glove , Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)