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

    STERILE SURGICAL LATEX GLOVE

    K Number: K881821 · Decision Jun 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    556
    Applicant Total
    1
    Review Days
    33

    Basic Information

    Device Name
    STERILE SURGICAL LATEX GLOVE
    K Number
    K881821
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    NCA MED INTL./NOBLE HOUSE, INC.
    Date Received
    April 29, 1988
    Decision Date
    June 1, 1988
    Product Code
    KGO
    Advisory Committee
    General, Plastic Surgery
    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
    KGO Surgeon'S Gloves

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