BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tested for Use with Chemotherapy Drugs

    Reg #: 3010194621 · FEI: 3010194621 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    LABOTEK GROUP CORP
    Registration Number
    3010194621
    FEI Number
    3010194621
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    CARR 174 KM 4.5 BO JUAN SANCHEZ
    City
    Bayamon
    State
    PR
    ZIP
    00956
    Country
    US

    Regulatory Submissions

    510(k) Number
    K170136

    Owner / Operator

    Firm Name
    LABOTEK GROUP CORP.
    Operator Number
    10044096
    Address
    CARR 174 KM 4.5 BO JUAN SANCHEZ
    City
    Bayamon
    State
    PR
    Postal Code
    00956
    Country
    US
    Correspondent
    MARISOL AROCHO

    Products

    Device Name Product Code
    Medical Glove, Specialty LZC
    Polymer Patient Examination Glove LZA

    Proprietary Names

    Tested for Use with Chemotherapy Drugs TOUCH Chemo Tested Nitrile Exam Glove Powder Free Glove

    Establishment Types

    Repack or Relabel Medical Device