Breakout Session B (02/15): Risk Assessment in Action

Spontaneous Combustion of Latex Examination Gloves
Scott G. McNamee, Center for Devices and Radiological Health, Food and Drud Administration, Office of Science and Technology, Rockville, MD 20852

During 1994 and 1995, four warehouse fires were reported as having been caused by the spontaneous combustion of latex examination gloves stored therein. FDA was alerted to the problem and an investigation was initiated. Two risk assessment questions were raised while addressing this issue. The first question was "What is the risk of latex spontaneously combusting?" Latex does not ordinarily give rise to spontaneous combustion, so the suspect gloves were tested for excess generation of heat. The suspect gloves, which were powderfree latex examination gloves labeled as having been made in China and control powderfree latex examination gloves were taken through identical heating profiles while the internal temperature of the glove mass was monitored. A clear overheating by the suspect gloves indicated a potential for spontaneous combustion. The second risk assessment question was "What is the risk of this occurring again?" Infrared studies of both the surfaces (FTIR-ATR) of the gloves as well as extracts (FTIR-transmission) from the gloves showed a difference in the chemical makeup of the suspect gloves from control gloves. It was concluded that the latex gloves were improperly manufactured using inappropriate additives resulting in an unsafe product. A public health advisory was issued concerning the storage of suspect gloves.


CFSAN | FDA
Last updated on 2008-JUL-22 by frf