BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Latex PCPF Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural)

    Reg #: 8040614 · FEI: 3002807146 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HARTALEGA SDN BHD
    Registration Number
    8040614
    FEI Number
    3002807146
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 7, Kawasan Perusahaan Suria
    City
    Bestari Jaya Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K160928

    Owner / Operator

    Firm Name
    HARTALEGA SDN BHD
    Operator Number
    8040614
    Address
    C-G-9,Jalan Dataran SD1,Dataran SD PJU9, Bandar Sri Damansara
    City
    KUALA LUMPUR
    State
    MY-NOTA
    Postal Code
    52200
    Country
    MY
    Correspondent
    KUAN - KAM HON

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Surgeon'S Gloves KGO

    Proprietary Names

    Latex PCPF Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural) Latex PCPF Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility