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

    NEOLON NEOPRENE SURGICAL GLOVES

    K Number: K954325 · Decision May 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    26
    Review Days
    242

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    Basic Information

    Device Name
    NEOLON NEOPRENE SURGICAL GLOVES
    K Number
    K954325
    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
    Maxxim Medical
    Date Received
    September 15, 1995
    Decision Date
    May 14, 1996
    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 Maxxim Medical

    K Number Device Name
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    K002847 INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
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    K990173 PATHFINDER II ANGIOGRAPHIC CATHETER
    K992865 SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE
    K991615 POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE
    K992122 TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
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