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

    PATIENT EXAMINATION GLOVES (POLY)

    K Number: K892768 · Decision Jun 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    380
    Registration Numbers
    380
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    64

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    Basic Information

    Device Name
    PATIENT EXAMINATION GLOVES (POLY)
    K Number
    K892768
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Promedica Products, Inc.
    Date Received
    April 11, 1989
    Decision Date
    June 14, 1989
    Product Code
    LZA
    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
    LZA Polymer Patient Examination Glove

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