June 27, 1996
To: Hospital Administrators Latex Glove Manufacturers
Hospital Risk Managers Distributors/Importers
Hospital Procurement Managers
In the spring and summer of 1995, the spontaneous combustion of powder-free latex patient examination gloves caused four fires in different states. The fires all occurred in warehouses and involved large quantities of non-sterile, powder-free, chlorinated latex gloves stored on pallets. All of the gloves were labeled "Made in China" and manufacturers' serial numbers indicate they were manufactured between 1992 and 1994. We are concerned about the potential for future fires involving powder-free latex patient examination gloves and about glove quality. This Advisory offers recommendations which we believe will help reduce risks.
Investigations by the Food and Drug Administration (FDA), the Bureau of Alcohol, Tobacco, and Firearms (BATF), and local fire departments have identified the fires as having started within gloves stored in stacks on pallets. Having ruled out arson, investigators concluded the cause of the fires was spontaneous combustion of the gloves. High warehouse temperatures apparently accelerated an exothermic chemical reaction on the chlorinated gloves to the point where the latex ignited. This conclusion has been supported by current FDA research and raises continued concern as another hot season arrives. We are also concerned that heating short of ignition temperatures may cause the glove latex to deteriorate and lose its effectiveness as a barrier. (Note that labeling on glove boxes instructs that gloves should be stored in a cool and dry place.)
Although our investigation is not complete and research continues, we have identified several factors that may increase the potential risk for fires. The most important of these are the storage environment temperature and mass of the gloves. Therefore, do not store large quantities of powder-free latex patient examination gloves in conditions of extreme heat. Because all the known fires occurred in a quantity of at least one pallet in warehouses without temperature controls, we consider a large quantity of powder-free latex gloves to be one pallet or more stored in a warm to hot location. While it is not possible to identify a maximum safe storage temperature, research has confirmed that the greater the mass quantity of gloves, the cooler the temperature must be to avoid fires. The FDA recommends the following precautions:
- Avoid a large inventory of powder-free latex gloves.
- Remove shrink-wrap from pallets of stacked cartons.
- Break the stacked cartons on each pallet apart and restack or reconfigure cartons to facilitate cooling ventilation.
- Periodically check powder-free latex gloves for characteristics suggestingdeterioration, such as brittleness, tackiness, or an acrid chemical odor or stench.
- Rotate your powder-free latex glove stock using "first-in-first-out" practices.
If gloves exhibit any characteristic suggesting deterioration, they should not be used; it is doubtful they provide an adequate protective barrier. Should these characteristics be noted, or if evidence of combustion is observed:
(1) immediately break apart the stacks to dissipate heat,
(2) identify gloves as hazardous and quarantine or remove,
(3) contact your District FDA office or call FDA Emergency Operations at 1-866-300-4374 or 301-796-8240, and
(4) contact your local Health Department or local environmental agency regarding the proper disposition of hazardous materials.
FDA will continue to inspect glove manufacturers and distributors, and to work closely with U.S. Customs, to help ensure the quality of latex gloves in this country. As we learn more we will provide you with updates via CDRH Facts on Demand, which can be reached by calling 1(800)899-0381 or by accessing the FDA/CDRH Homepage on the Worldwide Web at http://www.fda.gov/cdrh/cdrhhome and look in New Items.
We are interested in any observations you or your employees may have regarding the quality of patient examination or surgeons' gloves that you distribute or purchase. We encourage you and your staff to use MedWatch, FDA's voluntary reporting program. Submit these reports to MedWatch by phone at (800)FDA-1088, by FAX at (800)FDA-1078, or mail to:
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
FDA Medical Device Public Health Notifications are available on the Internet. You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.
D. Bruce Burlington, M.D.
Center for Devices and Radiological Health
Food and Drug Administration