BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)

    Reg #: 3019769825 · FEI: 3019769825 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HARTALEGA NGC SDN. BHD. (LOT 39496)
    Registration Number
    3019769825
    FEI Number
    3019769825
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.2 (Lot 39496), Persiaran Tanjung, Kawasan Perindustrian Tanjung, Jalan B20,
    City
    Sepang Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K222225

    Owner / Operator

    Firm Name
    Hartalega NGC Sdn. Bhd. (Lot 39496)
    Operator Number
    10090827
    Address
    No.2 (Lot 39496), Persiaran Tanjung, Kawasan Perindustrian Tanjung, Jalan B20,
    City
    Sepang
    State
    Selangor
    Postal Code
    43900
    Country
    MY
    Correspondent
    Eu Jin Kuan

    Products

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

    Proprietary Names

    Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)