BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    PROFESSIONAL LATEX SDN BHD

    Reg #: 3019585047 · FEI: 3019585047 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    PROFESSIONAL LATEX SDN BHD
    Registration Number
    3019585047
    FEI Number
    3019585047
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lot 20734 & 20735, Lengkungan Perusahaan Kamunting 3/1, Kawasan Perusahaan Kamunting Raya,
    City
    Kamunting Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K220088

    Owner / Operator

    Firm Name
    Professional Latex Sdn Bhd
    Operator Number
    10055058
    Address
    Lot 52, Jalan Logam 2, Kamunting Raya
    City
    Kamunting
    State
    Perak
    Postal Code
    34600
    Country
    MY
    Correspondent
    Yoon Lim kok

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

    Proprietary Names

    LZC - Medical Glove, Specialty LZA - Polymer patient examination glove QDO - Fentanyl and other opioid protection glove OPJ - Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs Powder Free Latex Examination Glove Powder Free Nitrile Examination Glove

    Establishment Types

    Manufacture Medical Device