BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    Polyisoprene Surgical gloves

    K Number: K240790 · Decision Aug 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    3
    Review Days
    154

    Basic Information

    Device Name
    Polyisoprene Surgical gloves
    K Number
    K240790
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Suzhou Colour-way New Material Co., Ltd.
    Date Received
    March 22, 2024
    Decision Date
    August 23, 2024
    Product Code
    KGO
    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
    KGO Surgeon'S Gloves

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