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

    LATEX EXAMINATION GLOVE

    K Number: K904324 · Decision Oct 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    1
    Review Days
    19

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    Basic Information

    Device Name
    LATEX EXAMINATION GLOVE
    K Number
    K904324
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Gallimore Ent., Inc.
    Date Received
    September 14, 1990
    Decision Date
    October 3, 1990
    Product Code
    LYY
    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
    LYY Latex Patient Examination Glove

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