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

    DISPOSABLE LATEX EXAMINATION GLOVES

    K Number: K921438 · Decision Jun 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    DISPOSABLE LATEX EXAMINATION GLOVES
    K Number
    K921438
    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
    March 25, 1992
    Decision Date
    June 23, 1992
    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.

    K Number Device Name
    K922358 STERLING POWDER FREE PATIENT EXAMINATION GLOVES
    K924959 STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC
    K896707 PERLINK SCREEN, KIRAN SCREEN
    K901790 THERMOMETER, MERCURY/CLINICAL
    K896708 PERLINK CASSETTE, KIRAN CASSETTE