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

    ERGO II, SURGICAL LATEX GLOVES

    K Number: K884030 · Decision Nov 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    5
    Review Days
    45

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    Basic Information

    Device Name
    ERGO II, SURGICAL LATEX GLOVES
    K Number
    K884030
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Ergo Intl., Ent., Inc.
    Date Received
    September 23, 1988
    Decision Date
    November 7, 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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    Other Clearances by Ergo Intl., Ent., Inc.

    K Number Device Name
    K892166 NON-STERILE PATIENT EXAM GLOVES (LATEX)
    K892026 PROLAX PATIENT EXAMINATION GLOVES (LATEX)
    K892100 PATIENT EXAM GLOVES (MFG. SHUN JUN TRADING CO.)
    K892101 PATIENT EXAM GLOVES (MFG. SHUN TAHI RUBBER GLOVES)