BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    SemperForce Blue Nitrile NBR PF OB 100pc

    Reg #: 8041003 · FEI: 3009157666 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    4

    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
    K223903

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

    Proprietary Names

    SemperForce Blue Nitrile NBR PF OB 100pc Nitrile SPK-030VB NBR PF VB 6pc SP (Sample Gloves) Tender Touch NBR PF VB 100pc M StarMed Ultra Nitrile NBR PF VB 250pc StarMed Select NBR PF VB 100pc Nitrile Exam NBR PF OB (IMCO) StarMed Plus NBR PF VB 300pc semperguard Xpert Tender Touch NBR PF VB 200pc Nitrile Exam 200 NBR PF VB 200pc (IMCO) Nitrile SPK-035VB NBR PF VB 6pc SP (Sample Gloves) semperguard force blue

    Establishment Types

    Manufacture Medical Device