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    FDA Registration Active 🇲🇾 Malaysia

    SemperSure Green Nitrile Examination Gloves (SUNG201-SUNG205)

    Reg #: 8041003 · FEI: 3009157666 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    LATEXX MANUFACTURING SDN. BHD.
    Registration Number
    8041003
    FEI Number
    3009157666
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 18374, JALAN PERUSAHAAN 3, KAMUNTING INDUSTRIAL ESTATE
    City
    TAIPING Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K183441

    Owner / Operator

    Firm Name
    Latexx Manufacturing Sdn. Bhd.
    Operator Number
    8041003
    Address
    LOT 18374, JALAN PERUSAHAAN 3,, KAMUNTING INDUSTRIAL ESTATE
    City
    TAIPING
    State
    Perak
    Postal Code
    34600
    Country
    MY

    US Agent

    Business Name
    Mansour Consulting LLC
    Contact Name
    Jay Mansour
    Address
    845 Aronson Lake Court
    City
    Roswell
    State
    GA
    ZIP
    30075
    Country
    US
    Email
    [email protected]
    Phone
    678 9088180

    Products

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

    Proprietary Names

    SemperSure Green Nitrile Examination Gloves (SUNG201-SUNG205) Powder-Free Nitrile Patient Examination Glove, Green Colored, Non-Sterile, Low Dermatitis Potential, And Tested For Use

    Establishment Types

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