BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ANSELL HEALTHCARE PRODUCTS LLC

    Reg #: 3009964047 · FEI: 3009964047 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ANSELL HEALTHCARE PRODUCTS LLC
    Registration Number
    3009964047
    FEI Number
    3009964047
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    111 Wood Ave S Suite 210
    City
    Iselin
    State
    NJ
    ZIP
    08830
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203705

    Owner / Operator

    Firm Name
    ANSELL HEALTHCARE PRODUCTS LLC
    Operator Number
    8020065
    Address
    2301 Robb Drive
    City
    Reno
    State
    NV
    Postal Code
    89523
    Country
    US
    Correspondent
    Don Cronk

    Products

    Device Name Product Code
    Latex Patient Examination Glove LYY
    Polymer Patient Examination Glove LZA

    Proprietary Names

    LATEX EXAMINATION GLOVE, POWDER FREE WITH PROTEN CONTENT LABELING CLAIM (50 ug/g or less of total extractable Protein)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device