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

    PATIENT EXAMINATION GLOVES (LATEX)

    K Number: K892623 · Decision Sep 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    1953
    Applicant Total
    5
    Review Days
    154

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    Basic Information

    Device Name
    PATIENT EXAMINATION GLOVES (LATEX)
    K Number
    K892623
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Globe Ent., Inc.
    Date Received
    April 10, 1989
    Decision Date
    September 11, 1989
    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 Globe Ent., Inc.

    K Number Device Name
    K972854 PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY
    K972839 PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET
    K972843 PROTOS BLOOD TRANSFUSION SET
    K884622 SURGICAL GLOVES