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

    STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC

    K Number: K924959 · Decision Mar 3, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    154

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    Basic Information

    Device Name
    STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC
    K Number
    K924959
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Perlink USA, Inc.
    Date Received
    September 30, 1992
    Decision Date
    March 3, 1993
    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 Perlink USA, Inc.

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    K921438 DISPOSABLE LATEX EXAMINATION GLOVES
    K896707 PERLINK SCREEN, KIRAN SCREEN
    K901790 THERMOMETER, MERCURY/CLINICAL
    K896708 PERLINK CASSETTE, KIRAN CASSETTE