(We encourage you to copy and distribute this Advisory)
FDA Public Health Advisory:
Potential Risk of Spontaneous Combustion
in Large Quantities of Patient Examination Gloves
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 suggesting
deterioration, 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 (301)443-1240, 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:
MedWatch
Food and Drug Administration
HF-2
5600 Fishers Lane
Rockville, Maryland 20857.
If you have questions about this Public Health Advisory, please contact the Issues Management
Staff, Office of Surveillance and Biometrics, Center for Devices and Radiological Health,
Food and Drug Administration, HFZ-510, 1350 Piccard Drive, Rockville, Maryland, 20850,
by FAX at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. Additionally, a voice mail
message may be left at 240-276-3357 and your call will be returned as soon as possible.
Sincerely yours,
D. Bruce Burlington, M.D.
Director
Center for Devices and Radiological Health
Updated June 26, 1996
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