BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    ONETEXX SDN BHD

    Reg #: 3019252794 · FEI: 3019252794 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    ONETEXX SDN BHD
    Registration Number
    3019252794
    FEI Number
    3019252794
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No: 73 - 86, Jalan Logam 5, Perindustrian Kamunting 3,, Kamunting Raya Industrial Park
    City
    Kamunting Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K210366

    Owner / Operator

    Firm Name
    Onetexx Sdn Bhd
    Operator Number
    10081868
    Address
    No: 73 - 86, Jalan Logam 5, Perindustrian Kamunting 3,, Kamunting Raya Industrial Park
    City
    Kamunting
    State
    Perak
    Postal Code
    34600
    Country
    MY
    Correspondent
    Freddy Low

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

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

    Proprietary Names

    Blue Nitrile Powder Free Patient Examination Glove, Non Sterile Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile Kenaflexx Nitrile Examination Gloves Powder Free Black Black Nitrile Powder Free Patient Examination Glove, Non Sterile White Nitrile Powder Free Patient Examination Glove, Non Sterile LYDUS Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fe Nitrile Powder Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simula

    Establishment Types

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