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

    NITRILON CORRECT-TOUCH

    K Number: K984512 · Decision Jul 12, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    3
    Review Days
    206

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    Basic Information

    Device Name
    NITRILON CORRECT-TOUCH
    K Number
    K984512
    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
    Ct Intl.
    Date Received
    December 18, 1998
    Decision Date
    July 12, 1999
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Expedited Review
    Y
    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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    Other Clearances by Ct Intl.

    K Number Device Name
    K981304 NITRILON CORRECT-TOUCH
    K891622 STERILE SURGICAL NATURAL LATEX GLOVES