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

    PERRY XTENDA CUFF SURGICAL GLOVES

    K Number: K905537 · Decision Jan 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    10
    Review Days
    31

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    Basic Information

    Device Name
    PERRY XTENDA CUFF SURGICAL GLOVES
    K Number
    K905537
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Smith & Nephew Perry
    Date Received
    December 11, 1990
    Decision Date
    January 11, 1991
    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 Smith & Nephew Perry

    K Number Device Name
    K932665 ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC
    K932664 ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIA
    K931399 PERRY ENHANCED PROTECTION LATEX SURGICAL GLOVE
    K923929 PERRY POWDER-FREE GLOVES, STYLE 45G
    K922379 STERILE LATEX EXAMINATION GLOVES
    K914445 PERRY(R) NATURAL POWDER-FREE GLOVES, STYLE 45
    K914942 PERRY(R) CUT-RESISTANT GLOVES
    K913402 PERRY(R) DERMAGUARD(R) PLUS GLOVES
    K911633 PERRY(R) ENCORE CHEMOTHERAPY GLOVE