BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff

    Reg #: 3014449454 · FEI: 3014449454 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    J&H FULFILLMENT LLC
    Registration Number
    3014449454
    FEI Number
    3014449454
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    955 N WEIGEL AVENUE, Suite 100
    City
    Elmhurst
    State
    IL
    ZIP
    60126
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193666

    Owner / Operator

    Firm Name
    J&H FULFILLMENT LLC
    Operator Number
    10059066
    Address
    955 N WEIGEL AVENUE, Suite 100
    City
    Elmhurst
    State
    IL
    Postal Code
    60126
    Country
    US

    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

    Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff

    Establishment Types

    Repack or Relabel Medical Device