BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs

    Reg #: 3011200663 · FEI: 3011200663 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HARTALEGA NGC SDN BHD
    Registration Number
    3011200663
    FEI Number
    3011200663
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung
    City
    Sepang Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K201748

    Owner / Operator

    Firm Name
    HARTALEGA NGC SDN BHD
    Operator Number
    10047371
    Address
    No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung
    City
    Sepang
    State
    Selangor
    Postal Code
    43900
    Country
    MY
    Correspondent
    KUAN MUN LEONG

    Products

    Device Name Product Code
    Medical Glove, Specialty LZC
    Surgeon'S Gloves KGO

    Proprietary Names

    Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)