BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE

    Reg #: 8040793 · FEI: 3003218972 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KOON SENG SDN.BHD
    Registration Number
    8040793
    FEI Number
    3003218972
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PTD 3274 BATU 4 1/2, JALAN BAKRI
    City
    MUAR Johor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K093375

    Owner / Operator

    Firm Name
    KOON SENG SDN.BHD
    Operator Number
    8040793
    Address
    PTD 16058, KAWASAN PERINDUSTRIAN TANGKAK, JALAN MUAR
    City
    TANGKAK
    State
    Johor
    Postal Code
    84900
    Country
    MY

    US Agent

    Business Name
    MDI CONSULTANTS, INC.
    Contact Name
    ALAN SCHWARTZ
    Address
    55 NORTHERN BLVD., SUITE 200
    City
    GREAT NECK
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Latex Patient Examination Glove LYY

    Proprietary Names

    KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)

    Establishment Types

    Manufacture Medical Device