BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    ECO MEDI GLOVE SDN BHD

    Reg #: 3010763223 · FEI: 3010763223 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    ECO MEDI GLOVE SDN BHD
    Registration Number
    3010763223
    FEI Number
    3010763223
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lot 23826,. Jalan Tembaga Kuning, Kawasan Perindustrian Kamunting Raya
    City
    Taiping Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K220943

    Owner / Operator

    Firm Name
    ECO Medi Glove SDN BHD
    Operator Number
    10047533
    Address
    Lot 23826,Jalan Tembaga Kuning, Kawasan Perindustrian 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
    Polymer Patient Examination Glove LZA
    Medical Glove, Specialty LZC
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Fentanyl And Other Opioid Protection Glove QDO

    Proprietary Names

    Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim EMG Blue Nitrile Examination Glove Powder Free with tested for used with Chemotherapy Drugs Powder Free Nitrile Examination Glove (Aqua Green) EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented Get-A-Grip Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim EMG Pink Nitrile Examination Glove Powder Free Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims Blue Nitrile Examination Gloves Powder free with tested for use with Chemotherapy Drugs Labeling Claim NitraCare N8850XPB N8840XPB Cardinal Health Nitrile Examination Glove Extended Cuff

    Establishment Types

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