BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PolyWear Personal Protective Level 3 Gown

    Reg #: 1423205 · FEI: 3001239227 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POLYCONVERSIONS, INC.
    Registration Number
    1423205
    FEI Number
    3001239227
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3202 Apollo Drive
    City
    Champaign
    State
    IL
    ZIP
    61822
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230384

    Owner / Operator

    Firm Name
    PolyConversions, Inc.
    Operator Number
    9047406
    Address
    3202 Apollo Drive, --
    City
    Champaign
    State
    IL
    Postal Code
    61822
    Country
    US
    Correspondent
    William B Smith

    Products

    Device Name Product Code
    Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection QPC

    Proprietary Names

    PolyWear Personal Protective Level 3 Gown

    Establishment Types

    Manufacture Medical Device