BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Gloves

    Reg #: 3010605427 · FEI: 3010605427 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HARPS Investment Asia Pte. Ltd.
    Registration Number
    3010605427
    FEI Number
    3010605427
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Straits View, #08-10A, Marina One West Tower
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K070072

    Owner / Operator

    Firm Name
    HARPS Investment Asia Pte. Ltd.
    Operator Number
    10045460
    Address
    9 Straits View, #08-10A, Marina One West Tower
    City
    Singapore
    State
    SG-NOTA
    Postal Code
    018937
    Country
    SG

    US Agent

    Business Name
    Mansour Consulting LLC
    Contact Name
    Jay Mansour
    Address
    845 Aronson Lake Court
    City
    Roswell
    State
    GA
    ZIP
    30075
    Country
    US
    Email
    [email protected]
    Phone
    678 9088180

    Products

    Device Name Product Code
    Latex Patient Examination Glove LYY

    Proprietary Names

    Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber Latex Examination Gloves Health Shield 50ct PF Latex EXAM NR PF Dealmed Latex NR PF Guardian NR PF GlovePak Azurite PF NBR VB Grainger Condor Latex NR PF Rely-a-Grip LP NR PF CareMates 50CT PF SemperCare Latex PF Essential Cares Latex NR PF Pro-Medix Exam NR PF Winco 50ct PF ADM Tex Latex GMX Textured PF Latex SemperCare Latex SPK NR PF

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility