BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim

    Reg #: 3016413634 · FEI: 3016413634 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ECO MEDI GLOVE SDN BHD
    Registration Number
    3016413634
    FEI Number
    3016413634
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lot 26910, Lorong Perusahaan 3/3, Kawasan Perusahaan, Kamunting Raya
    City
    Taiping Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K220672

    Owner / Operator

    Firm Name
    Eco Medi Glove Sdn Bhd
    Operator Number
    10061572
    Address
    Lot 26910, Lorong Perusahaan 3/3, Kamunting Raya Industrial Estate, Kamunting Raya
    City
    Taiping
    State
    Perak
    Postal Code
    34600
    Country
    MY

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

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

    Proprietary Names

    Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)