Validation of a corona discharge technique to test male latex condoms for pinhole defects

摘要

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 latexcondoms with laser-drilled holes ranging from approximately 1 to 30μm in diameter, we examined the sensitivity of this device. The smallest holes were detected, and the overall false negative rate was 2.