ISSN: 1945-7553
CODEN: JTEVAB
Page Count: 4

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

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

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

(Received 11 March 1998; accepted 18 September 1998)

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%.

Keywords:
latex, condoms, holes, electrical discharge

Paper ID: JTE12034J
DOI: 10.1520/JTE12034J
ASTM International is a member of CrossRef.