BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Labeling Claim (Blue, White)

    Reg #: 3007791481 · FEI: 3007791481 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PACEWELL ASIA SDN. BHD.
    Registration Number
    3007791481
    FEI Number
    3007791481
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 46-54 (PT9289, 9291, 9293-9297), Laluan Bemban, Kawasan Perindustrian Bemban
    City
    Batu Gajah Perak
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K162405

    Owner / Operator

    Firm Name
    Pacewell Asia Sdn. Bhd.
    Operator Number
    10026951
    Address
    55A, Medan Ipoh 1A, Medan Ipoh Bistari
    City
    Ipoh
    State
    Perak
    Postal Code
    31400
    Country
    MY
    Correspondent
    LEONG HON WENG

    Products

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

    Proprietary Names

    Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs Labeling Claim (Blue, White)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)