BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Medline Level 4 Surgical Gown with Breathable Sleeves

    K Number: K242844 · Decision Feb 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    29
    Review Days
    159

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    Basic Information

    Device Name
    Medline Level 4 Surgical Gown with Breathable Sleeves
    K Number
    K242844
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medline Industries, LP
    Date Received
    September 20, 2024
    Decision Date
    February 26, 2025
    Product Code
    FYA
    Advisory Committee
    General, Plastic Surgery
    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
    FYA Gown, Surgical

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