BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇲🇹 Malta

    NUTEX GLOVES

    K Number: K920745 · Decision Jan 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    4
    Review Days
    349

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    Basic Information

    Device Name
    NUTEX GLOVES
    K Number
    K920745
    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
    Ansell Intl.
    Date Received
    February 7, 1992
    Decision Date
    January 21, 1993
    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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    Other Clearances by Ansell Intl.

    K Number Device Name
    K904244 SENSIDERM
    K904769 SENSITOUCH
    K895781 ANSELL E.P. EXTRA-PROTECTION EXAMINATION GLOVES