BEUDAMED
    FDA Registration Active 🇹🇭 Thailand

    Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gast

    Reg #: 9614175 · FEI: 1000297006 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SAFESKIN MEDICAL & SCIENTIFIC (THAILAND), LTD.
    Registration Number
    9614175
    FEI Number
    1000297006
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    200 MOO 8 KANCHANAVANICH ROAD, TAMBOL PRIK
    City
    SADAO Songkhla
    Country
    TH

    Regulatory Submissions

    510(k) Number
    K213929

    Owner / Operator

    Firm Name
    O&M Halyard, Inc.
    Operator Number
    10057479
    Address
    1220 Old Alpharetta Rd, Suite 320
    City
    Alpharetta
    State
    GA
    Postal Code
    30005
    Country
    US
    Correspondent
    Angela Bunn

    US Agent

    Business Name
    O&M HALYARD, INC.
    Contact Name
    Angela Bunn
    Address
    1220 Old Alpharetta Rd Ste 320
    City
    Alpharetta
    State
    GA
    ZIP
    30005
    Country
    US
    Email
    [email protected]
    Phone
    470 3647147

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Fentanyl And Other Opioid Protection Glove QDO

    Proprietary Names

    Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gast

    Establishment Types

    Manufacture Medical Device