BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Cardinal Health Nitrile Exam Gloves

    K Number: K241780 · Decision Aug 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    26
    Review Days
    64

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    Basic Information

    Device Name
    Cardinal Health Nitrile Exam Gloves
    K Number
    K241780
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cardinal Health200, LLC
    Date Received
    June 20, 2024
    Decision Date
    August 23, 2024
    Product Code
    LZA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZA Polymer Patient Examination Glove

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