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    FDA Registration Active 🇮🇩 Indonesia

    Powder Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)

    Reg #: 8041150 · FEI: 3000239897 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    P.T. MAJA AGUNG LATEXINDO
    Registration Number
    8041150
    FEI Number
    3000239897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    JL.UTAMA NO.98 PUJI MULIO
    City
    SUNGGAL DELI SERDANG Sumatera Utara
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K212408

    Owner / Operator

    Firm Name
    P.T. MAJA AGUNG LATEXINDO
    Operator Number
    8041150
    Address
    JL. UTAMA NO. 98 PUJIMULIO, SUNGGAL DELI SERDANG
    City
    SUMATERA UTARA
    State
    ID-SU
    Postal Code
    20352
    Country
    ID
    Correspondent
    JANE - LAURENCE

    Products

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

    Proprietary Names

    Powder Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)

    Establishment Types

    Manufacture Medical Device