BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    PT. SINTONG UNIGOLDEN GLOVE

    Reg #: 3025303965 · FEI: 3025303965 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    PT. SINTONG UNIGOLDEN GLOVE
    Registration Number
    3025303965
    FEI Number
    3025303965
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    JL. LINTAS SUMATERA, HESSA PERLOMPONGAN, KEC. AIR BATU, KAB. ASAHAN, SUMATERA UTARA,
    City
    KISARAN Sumatera Utara
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K223235

    Owner / Operator

    Firm Name
    PT. SINTONG UNIGOLDEN GLOVE
    Operator Number
    10086606
    Address
    JL. LINTAS SUMATERA, KEL. HESSA PERLOMPONGAN,, KEC. AIR BATU, KAB. ASAHAN, SUMATERA UTARA,
    City
    KISARAN
    State
    Sumatera Utara
    Postal Code
    21272
    Country
    ID

    US Agent

    Business Name
    Liberty Management Group Ltd.
    Contact Name
    Manoj Zacharias
    Address
    75 Executive Drive,, Suite 114,
    City
    Aurora
    State
    IL
    ZIP
    60504
    Country
    US
    Email
    [email protected]
    Phone
    630 2702921

    Products

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

    Proprietary Names

    Nitrile Examination Glove Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) biodegradable powder free nitrile examination glove, blue and green colors, low dermatitis potential, tested for use with chemotherapy drugs, fentanyl citrate, simulated gastric acid and fentanyl citrate-simulated gastric acid solution biodegradable powder free nitrile examination glove, low dermatitis,potential claim, blue, green, black, white, orange, black-white, teal-gray, white-green, white-orange, white-blue, blue-white, green-white, orange-white colors Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device