Volume 29, Issue 2 (March 2001)

    Characterization and Creation of Defects in Condoms

    (Received 10 May 2000; accepted 31 October 2000)

    CODEN: JTEOAD

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    Abstract

    Defects in condoms were examined, then characterized and compared with defects introduced using various techniques. Eighty-five percent of the condom defects examined were classified as either a hole (void in material) or a slit (puncture). Laser drilling and puncturing with a 160 μm diameter acupuncture needle artificially introduced similar types of defects. Microscopic examination of the created defects, before and after FDA water leak testing, showed that this test method does not increase the size of preexisting microscopic defects. Examination also showed that these creation techniques generated reproducible defects within a condom type, with the size of acupuncture needle defects varying less than laser drilled defects. Results of water leak testing showed that the leakage characteristics of defects are affected by the material type, the condom shape and size, the type of defect and the defect size, and the presence of lubricant.


    Author Information:

    Kerr, LN
    Mechanical engineer, biologist, biomedical engineer, electronics engineer, and biologist, Winchester Engineering and Analytical Center, U. S. Food and Drug Administration, Winchester, MA

    Chaput, MP
    Mechanical engineer, biologist, biomedical engineer, electronics engineer, and biologist, Winchester Engineering and Analytical Center, U. S. Food and Drug Administration, Winchester, MA

    Boyd, SM
    Mechanical engineer, biologist, biomedical engineer, electronics engineer, and biologist, Winchester Engineering and Analytical Center, U. S. Food and Drug Administration, Winchester, MA

    Galevi, EA
    Mechanical engineer, biologist, biomedical engineer, electronics engineer, and biologist, Winchester Engineering and Analytical Center, U. S. Food and Drug Administration, Winchester, MA

    Millward, PA
    Mechanical engineer, biologist, biomedical engineer, electronics engineer, and biologist, Winchester Engineering and Analytical Center, U. S. Food and Drug Administration, Winchester, MA


    Stock #: JTE12248J

    ISSN: 0090-3973

    DOI: 10.1520/JTE12248J

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    Author
    Title Characterization and Creation of Defects in Condoms
    Symposium , 0000-00-00
    Committee D11