BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

    Reg #: 3005568780 · FEI: 3003116055 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    11
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
    Registration Number
    3005568780
    FEI Number
    3003116055
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LOT 821, JALAN MATANG, MATANG
    City
    TAIPING Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K162405

    Owner / Operator

    Firm Name
    COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
    Operator Number
    9008127
    Address
    LOT 821, JALAN MATANG, MATANG, --
    City
    TAIPING, PERAK
    State
    MY-NOTA
    Postal Code
    34750
    Country
    MY
    Correspondent
    CHAN - YEW MEN

    US Agent

    Business Name
    T. Cunningham Consulting & Associates, LLC
    Contact Name
    TERRELL CUNNINGHAM
    Address
    12812 Meadowbrook Ln
    City
    Waldorf
    State
    MD
    ZIP
    20601
    Country
    US
    Email
    [email protected]
    Phone
    301 5359600

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA
    Medical Glove, Specialty LZC
    Latex Patient Examination Glove LYY
    Fentanyl And Other Opioid Protection Glove QDO

    Proprietary Names

    Powder Free NItrile Examination Gloves Tested For Use with Chemotherapy Drugs Labeling Claim Olivia Claire Health Black Colored, Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Powder Free Natural Rubber Latex Examination Gloves- Blue, Non-Sterile and Protein Claim of 50mg/dm2 or Less Protein NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY Powder Free Nitrile Examination Gloves (Orange) Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labelling Claim (Black) LATEX EXAMINATION GLOVES Powder Free Nitrile Examination Gloves Tested For Use with Chemotherapy Drugs Labelling Claim (Green) Power Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl NITRILE EXAMINATIONGLOVES

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device