Bulk latex gloves blamed for fires

FDA Consumer, Jan-Feb, 1997 by Paula Kurtzweil

An import alert remains in effect for certain powder-free latex patient examination gloves imported from China. The gloves have the potential to spontaneously combust.

The patient examination gloves were imported by a California company and labeled "Made in China." Fire inspectors attributed three warehouse fires in 1995 to the gloves.

FDA issued the import alert in 1995, and, following an investigation, issued a public health advisory last summer to hospitals, manufacturers and distributors to inform them that powder-free latex examination gloves have the potential to ignite when stored in large quantities in extreme heat.

FDA continues to study the combustibility of imported powder-free latex examination gloves from China and other countries. According to John Farnham, a consumer safety officer in FDA's Center for Devices and Radiological Health, the United States imports 17 million shipments of latex medical gloves each year.

Powder-free latex gloves are believed to have caused fires in Memphis, Tenn., Middlesex, N.J., and New York City, in spring and summer 1995. In the latter, 67 firefighters were injured battling an eight-alarm fire at Brooklyn Navy Yard. The suspect gloves were imported from China by SJS Supreme Inc. of Yorba Linda, Calif.

FDA issued the import alert Aug. 7, 1995, calling for all shipments of powder-free latex examination gloves imported by SJS to be detained at their ports of entry. On Aug. 18, FDA sent SJS a letter, notifying the importer that, because of the fires, it would have to "eliminate the unreasonable risk of substantial harm ... to persons who may be directly or indirectly exposed to these devices."

SJS recalled the gloves. In a Sept. 18 letter, SJS asked the five distributors that had received shipments of the gloves to destroy their SJS powder-free latex examination glove inventory according to local laws on proper disposal of combustible materials.

That same month, FDA investigators inspected several Chinese latex examination glove manufacturing facilities and found "numerous GMP [good manufacturing practice] violations," according to Dan Rowland, a compliance officer with FDA's Los Angeles district office. FDA officials also contacted the State Pharmaceutical Administration of China, the Chinese agency that regulates medical devices in that country.

In early 1996, the Office of Science and Technology in FDA's Center for Devices and Radiological Health tested the thermal stability of imported powder-free latex examination gloves by exposing them to heat. The tests revealed that the SJS-imported gloves produced more heat than that to which they were exposed, suggesting that the gloves were capable of spontaneous combustion.

Scientists with FDA's Forensic Chemistry Center in Cincinnati then compared the heat-producing gloves to non-heating ones and found chemical differences between the two. The center is now working on a test to detect gloves that could spontaneously ignite.

FDA's public health advisory, issued June 27,1996, urged hospitals, distributors, and other facilities that store large quantities of powder-free patient examination gloves to take certain precautions to reduce the risk of the gloves igniting. FDA advised these businesses to avoid large inventories of powder-free latex examination gloves and to break apart stacked cartons to allow air to circulate more freely.

FDA's research indicated that higher temperatures short of ignition could cause latex gloves to deteriorate and lose their effectiveness as an adequate barrier. So, the agency's health advisory also cautioned hospitals and distributors to check powder-free latex examination gloves regularly for brittleness, tackiness, and an acrid chemical odor--all signs of latex glove deterioration.

According to FDA's Rowland, the agency is working with the U.S. Customs Service to determine how best to handle one last shipment of the suspect powder-free gloves detained in Los Angeles.