BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    GALLANT QUALITY SDN. BHD.

    Reg #: 9613998 · FEI: 3006581410 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    GALLANT QUALITY SDN. BHD.
    Registration Number
    9613998
    FEI Number
    3006581410
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LOT 1874, JALAN KAMPUNG DEW
    City
    TAIPING, PERAK
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K092874

    Owner / Operator

    Firm Name
    GALLANT QUALITY SDN BHD
    Operator Number
    9103901
    Address
    LOT 1874, JALAN KAMPUNG DEW, --
    City
    TAIPING, PERAK
    State
    MY-NOTA
    Postal Code
    34700
    Country
    MY
    Correspondent
    LEONG - CHOI LING

    US Agent

    Business Name
    T. Cunningham Consulting & Associates, LLC
    Contact Name
    TERRELL CUNNINGHAM
    Address
    12812 Meadowbrook Ln
    City
    Waldorf
    State
    MD
    ZIP
    20601
    Country
    US
    Email
    [email protected]
    Phone
    301 5359600

    Products

    Device Name Product Code
    Medical Glove, Specialty LZC
    Polymer Patient Examination Glove LZA
    Fentanyl And Other Opioid Protection Glove QDO
    Latex Patient Examination Glove LYY

    Proprietary Names

    Olivia Claire Health Nitrile Examination Gloves Blue Colored, Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Powder Free Nitrile (Orange) Examination Gloves Powder Free Nitrile (Black) Examination Gloves VGUARD Nitrile PF Exam NITRILE EXAMINATION GLOVES PATIENT PF LATEX EXAMINATION GLOVES Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Labeling Claim Green Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labelling Claim (Black) Powder-Free Blue Nitrile Examination Gloves with Tested For Use with Chemotherapy Drugs Labeling Claim

    Establishment Types

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