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

    PATIENT EXAMINATION GLOVE/HYPOALLERGENIC

    K Number: K905109 · Decision Nov 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    7
    Review Days
    8

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    Basic Information

    Device Name
    PATIENT EXAMINATION GLOVE/HYPOALLERGENIC
    K Number
    K905109
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Tactyl Technologies, Inc.
    Date Received
    November 13, 1990
    Decision Date
    November 21, 1990
    Product Code
    FMC
    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
    FMC Patient Examination Glove

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    Other Clearances by Tactyl Technologies, Inc.

    K Number Device Name
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    K953583 LUBRICATED CONDOM
    K950185 TACTYLON(TM) POWDER FREE SURGEONS GLOVE
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