Volume 27, Issue 1 (January 1999)

    Validation of a Corona Discharge Technique to Test Male Latex Condoms for Pinhole Defects

    (Received 11 March 1998; accepted 18 September 1998)

    CODEN: JTEOAD

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    Abstract

    The Center for Devices and Radiological Health, Food and Drug Administration, evaluated a prototype device using novel technology to detect pinholes in male latex condoms. This device uses multiple electrodes, maintained at high positive voltage, which interrogate a latex condom placed on a conducting mandrel. An electric discharge occurs only when a small hole is present in the condom and is sensed by the device. The mandrel is rotated to map out the entire surface of the condom. Using latex condoms with laser-drilled holes ranging from approximately 1 to 30 µm in diameter, we examined the sensitivity of this device. The smallest holes were detected, and the overall false negative rate was 2%.


    Author Information:

    Herman, BA
    U.S. Food and Drug Administration, Rockville, MD

    Carey, RF
    U.S. Food and Drug Administration, Rockville, MD


    Stock #: JTE12034J

    ISSN: 0090-3973

    DOI: 10.1520/JTE12034J

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    Author
    Title Validation of a Corona Discharge Technique to Test Male Latex Condoms for Pinhole Defects
    Symposium , 0000-00-00
    Committee D11