BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Azer Gloves Standard Nitrile

    Reg #: 3009963993 · FEI: 3009963993 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AZER SCIENTIFIC, INC.
    Registration Number
    3009963993
    FEI Number
    3009963993
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    701 Hemlock Rd
    City
    Morgantown
    State
    PA
    ZIP
    19543
    Country
    US

    Regulatory Submissions

    510(k) Number
    K993876

    Owner / Operator

    Firm Name
    Azer Scientific, Inc.
    Operator Number
    9062234
    Address
    701 Hemlock Road, --
    City
    Morgantown
    State
    PA
    Postal Code
    19543
    Country
    US
    Correspondent
    Flip - Britton

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA

    Proprietary Names

    Azer Gloves Standard Nitrile Azer Nitrile Ultra Gloves TrueForm Vertex X6 TrueForm Extra Thin Nitrile Azer Nitrile Plus Gloves Azer Nitrile Ultra Aloe Gloves TrueForm Everyday Nitrile

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device