BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    NATURAL-TOUCH (TM) SURGEON'S GLOVE

    K Number: K872996 · Decision Mar 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    3
    Review Days
    214

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    Basic Information

    Device Name
    NATURAL-TOUCH (TM) SURGEON'S GLOVE
    K Number
    K872996
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Hands-On Packaging , Ltd.
    Date Received
    August 3, 1987
    Decision Date
    March 4, 1988
    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 Hands-On Packaging , Ltd.

    K Number Device Name
    K892168 LATEX EXAM GLOVES (SURGICAL TYPE GLOVE)
    K892169 PATIENT EXAMINATION GLOVES (LATEX)