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

    REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE

    K Number: K971514 · Decision Oct 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    187

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    Basic Information

    Device Name
    REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE
    K Number
    K971514
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    London International Group, Inc.
    Date Received
    April 25, 1997
    Decision Date
    October 29, 1997
    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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    Other Clearances by London International Group, Inc.

    K Number Device Name
    K991677 REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
    K984249 SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE
    K980942 REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE
    K980516 REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE