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May 11, 2011
Facts about a Proposed Ban on Cornstarch Powder and Natural Rubber Latex Gloves
On 25 April 2011, a Washington, D.C. based consumer advocacy group called Private Citizen filed a 14-page petition with the Food and Drug Administration calling for an immediate ban on cornstarch powder on all surgeon’s and patient examination gloves. This petition also calls for an immediate ban on the use of all natural rubber latex (NRL) medical gloves. The petition was prompted by what Public Citizen perceives as “the serious threat posed by these products to patients and healthcare workers.” Public Citizen filed a similar petition in 1998, which requested the immediate ban on the use of cornstarch in medical gloves. This petition was rejected by FDA, who noted that such a ban “would not address exposure to NL [natural latex] allergens from medical gloves with high levels of NL proteins. Moreover, such a ban of powdered gloves might compromise the availability of high quality medical gloves” (FDA 1999). In the current petition, Public Citizen cites “FDA’s prolonged failure to take action eliminating the dangers posed by powdered surgeons and patient examination gloves.” Oat starch, which is used as a donning lubricant in some gloves, is not mentioned in the petition.

All gloves manufactured with NRL are currently required to carry a caution statement. In response to additional requests to eliminate powdered gloves, the FDA issued in February 2011 a draft guidance document entitled “Recommended Warning for Surgeon’s Gloves and Patient Examination Glove that Use Powder” (see SemperGram dated April 27, 2011; “FDA Issues Draft Guidance Regarding Powdered Gloves”).

In support of their petition to ban the use of natural rubber latex medical gloves, Private Citizen cited the number of reported serious allergic reactions in the FDA database. Since 2005, only ten such reactions have been documented by healthcare workers and patients. Conversely, over 30 billion NRL examination gloves were sold in the United States in 2009 alone, amounting to roughly 35% of the glove market (Thill 2010). The total number of health-related events, as a percentage of all NRL gloves used, is minute.

The immediate ban of all NRL gloves from the US market would place a significant burden on healthcare providers to obtain the required quantity of synthetic alternatives, especially given the current worldwide production capacity. Despite the downward trend in NRL glove use, the majority of healthcare workers still prefer the physical properties of NRL. Powdered latex gloves are usually less expensive than their powder-free and synthetic counterparts, thus they are favored by many budget-conscience users. The selection of low protein powder-free latex gloves, as well as powder-free synthetic gloves, significantly reduces the potential risks associated with allergic reactions.

References - Food and Drug Administration. 1999. Surgeon’s and patient examination gloves; reclassification. Federal Register 64:41710-41743. - Thill, L. 2010. Nitrile challenges latex as exam glove of choice. Repertoire 18:60-64.