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

    STERILE LATEX EXAMINATION GLOVES

    K Number: K903447 · Decision Sep 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    2
    Review Days
    54

    Basic Information

    Device Name
    STERILE LATEX EXAMINATION GLOVES
    K Number
    K903447
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    SIME DARBY USA
    Date Received
    July 27, 1990
    Decision Date
    September 19, 1990
    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 SIME DARBY USA

    K Number Device Name
    K891434 PATIENT EXAMINATION GLOVES (LATEX)