BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AMERICAN NITRILE OPERATIONS LLC

    Reg #: 3024755882 · FEI: 3024755882 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AMERICAN NITRILE OPERATIONS LLC
    Registration Number
    3024755882
    FEI Number
    3024755882
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3500 Southwest Blvd
    City
    Grove City
    State
    OH
    ZIP
    43123
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220373

    Owner / Operator

    Firm Name
    American Nitrile Operations LLC
    Operator Number
    10086326
    Address
    3500 Southwest Blvd
    City
    Grove City
    State
    OH
    Postal Code
    43123
    Country
    US
    Correspondent
    Tracy Calkins

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA
    Fentanyl And Other Opioid Protection Glove QDO

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)