BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    LATEXX MANUFACTURING SDN. BHD.

    Reg #: 8041003 · FEI: 3009157666 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    38
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    LATEXX MANUFACTURING SDN. BHD.
    Registration Number
    8041003
    FEI Number
    3009157666
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LOT 18374, JALAN PERUSAHAAN 3, KAMUNTING INDUSTRIAL ESTATE
    City
    TAIPING Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K171378

    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
    Latex Patient Examination Glove LYY
    Surgeon'S Gloves KGO
    Fentanyl And Other Opioid Protection Glove QDO
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ

    Proprietary Names

    Starmed Ultra Nitrile Starmed Ultra Fresen Patient examination glove, specialty Black Colour Powder-Free Nitrile Rubber Examination Gloves Powdered Latex Examination Gloves Polymer patient examination glove Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Gloves StarMed Plus Surgeon's gloves Nitrile Cornflower Blue Powder-Free Exam Tested for Use with Chemotherapy Drugs (Non-Sterile) Patient Examination Gloves (Latex) Semperguard Xpert Sempermed Safe Semperguard Force+ Latex patient examination glove Latex Examination Powder-Free Gloves Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves Nitrile SPK-035VB NBR PF VB 6pc SP (Sample Gloves) StarMed Select NBR PF VB 100pc StarMed Plus NBR PF VB 300pc Tender Touch NBR PF VB 100pc M SemperForce Blue Nitrile NBR PF OB 100pc Nitrile Exam 200 NBR PF VB 200pc (IMCO) Nitrile SPK-030VB NBR PF VB 6pc SP (Sample Gloves) semperguard force blue Nitrile Exam NBR PF OB (IMCO) Tender Touch NBR PF VB 200pc StarMed Ultra Nitrile NBR PF VB 250pc semperguard Xpert Powder-Free Blue Nitrile Examination Gloves with Tested For Use with Chemotherapy Drugs labeling Claim Nitrile Powdered-Free Examination Glove with Lotion Coating And use for Chemotherapy Powder-Free Nitrile Patient Examination Glove, Green Colored, Non-Sterile, Low Dermatitis Potential, And Tested For Use SemperSure Green Nitrile Examination Gloves (SUNG201-SUNG205) Qtexx Powder-Free Latex Examination Gloves with 50 Micrograms or Less of Total Water Extractable Protein Per Gram Proflex* Powder Free Nitrile Examiantion Gloves Nitrile Examination Powder-Free Gloves

    Establishment Types

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