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

    TACTYLON POWDER FREE EXAMINATION GLOVE

    K Number: K955464 · Decision Apr 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    7
    Review Days
    147

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    Basic Information

    Device Name
    TACTYLON POWDER FREE EXAMINATION GLOVE
    K Number
    K955464
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tactyl Technologies, Inc.
    Date Received
    November 30, 1995
    Decision Date
    April 25, 1996
    Product Code
    LZA
    Advisory Committee
    General Hospital
    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
    LZA Polymer Patient Examination Glove

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    Other Clearances by Tactyl Technologies, Inc.

    K Number Device Name
    K955419 POWDER FREE TACTYLON SURGEONS GLOVE
    K953583 LUBRICATED CONDOM
    K950185 TACTYLON(TM) POWDER FREE SURGEONS GLOVE
    K911431 TACTYLON(TM) CONDOM
    K905109 PATIENT EXAMINATION GLOVE/HYPOALLERGENIC
    K902831 TACTYLON TM SURGICAL GLOVE