BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    ANSELL SEREMBAN SDN. BHD

    Reg #: 3010436932 · FEI: 3010436932 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    ANSELL SEREMBAN SDN. BHD
    Registration Number
    3010436932
    FEI Number
    3010436932
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate
    City
    Seremban Negeri Sembilan
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K203705

    Owner / Operator

    Firm Name
    ANSELL HEALTHCARE PRODUCTS LLC
    Operator Number
    8020065
    Address
    2301 Robb Drive
    City
    Reno
    State
    NV
    Postal Code
    89523
    Country
    US
    Correspondent
    Don Cronk

    US Agent

    Business Name
    ANSELL HEALTHCARE PRODUCTS LLC
    Contact Name
    Don Cronk
    Address
    2301 Robb Drive
    City
    Reno
    State
    NV
    ZIP
    89523
    Country
    US
    Email
    [email protected]
    Phone
    775 4707106

    Products

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

    LATEX EXAMINATION GLOVE, POWDER FREE WITH PROTEN CONTENT LABELING CLAIM (50 ug/g or less of total extractable Protein) Supreno SE SU-690 POWDER FREE NITRILE EXAMINATION GLOVE WHITE (colored) Micro-Touch Royal Blue Cobalt ® N19X GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS PI Hybrid Micro POWDER FREE NITRILE EXAMINATION GLOVE BLACK AND DURAL COLOR WHITE-BLUE MICROFLEX MIDKNIGHT MK-296

    Establishment Types

    Manufacture Medical Device