BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate

    Reg #: 3038187455 · FEI: 3038187455 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    PT K-TECH INDUSTRIES
    Registration Number
    3038187455
    FEI Number
    3038187455
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Jalan Surfaktan Kavling C8 - C9, KEK Sei Mangkei, Desa/Kelurahan Sei Mangkei, Kec. Bosar Maligas, Kab.
    City
    Simalungun Sumatera Utara
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K243792

    Owner / Operator

    Firm Name
    PT K-Tech Industries
    Operator Number
    10093197
    Address
    Jalan Surfaktan Kavling C8 - C9, KEK Sei Mangkei, Desa/Kelurahan Sei Mangkei, Kec. Bosar Maligas, Kab.
    City
    Simalungun
    State
    Sumatera Utara
    Postal Code
    21183
    Country
    ID
    Correspondent
    Aditya Pratama

    US Agent

    Business Name
    Primemax
    Contact Name
    Max Lee
    Address
    805 BARRINGTON AVE.
    City
    Ontario
    State
    CA
    ZIP
    91764
    Country
    US
    Email
    [email protected]
    Phone
    909 9801678

    Products

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

    Proprietary Names

    Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device