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

    NON-STERILE PATIENT EXAMINATION GLOVES

    K Number: K905755 · Decision Mar 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    169
    Registration Numbers
    169
    Same Product Code
    1953
    Applicant Total
    14
    Review Days
    71

    Basic Information

    Device Name
    NON-STERILE PATIENT EXAMINATION GLOVES
    K Number
    K905755
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6250
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    SUPERIOR HEALTHCARE GROUP, INC.
    Date Received
    December 27, 1990
    Decision Date
    March 8, 1991
    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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