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

    POWDER FREE STERILE LATEX SURGEONS GLOVES

    K Number: K950468 · Decision Apr 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    138
    Registration Numbers
    138
    Same Product Code
    558
    Applicant Total
    6
    Review Days
    81

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    Basic Information

    Device Name
    POWDER FREE STERILE LATEX SURGEONS GLOVES
    K Number
    K950468
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4460
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intl. Trade Management Co.
    Date Received
    February 3, 1995
    Decision Date
    April 25, 1995
    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 Intl. Trade Management Co.

    K Number Device Name
    K954462 POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES
    K953299 POLYKOTE
    K951513 JAI
    K950467 POWDER FREE PATIENT EXAMINATION GLOVES
    K946203 JAI POWDERFREE LATEX EXAMINATION GLOVES