FDA Ban Medical Gloves: Proposal Eliminates Powdered Latex

The FDA wants to ban medical gloves covered in white powder. A proposal issued by the U.S. Food and Drug Administration (FDA) on Monday would eliminate the use of all powdered latex medical gloves. Powdered natural latex gloves pose potential serious health risks to patients, concluded the FDA, following comments received on a public federal register notice regarding the risks versus the benefits of using powdered gloves in the medical industry.

Two citizen petitions received by the FDA prompted the organization to take a closer look at powdered surgeon and patient examination gloves. The petitions highlight some of the adverse health risks that white dusting powder on latex gloves can pose to both providers and patients, including allergic reactions, inflammation, irritation, and respiratory reactions.

The public notice, titled Information Related to Risks and Benefits of Powdered Gloves, was posted by the FDA on the Regulations.gov website over five years ago, on February 7, 2011. Only two months later, in April, 2011, the document was closed for public comments. But in that short amount of time, the FDA managed to gather 285 public comments. Negative comments prompted the FDA to announce the proposal this week to ban donning powder on medical gloves.

“As I have read and submitted comments to the FDA, I have been worried to see the well documented comments of patients and healthcare workers who have been injured by cornstarch on medical gloves. In my search through the scientific literature, I have not seen one scientific publication that confirms cornstarch on medical gloves is safe. As we approach April 25, 2011, I would expect that the FDA would ban cornstarch on exam/medical gloves in the United States immediately. I will check daily on the news to learn of the decision of the FDA to ban the dangerous cornstarch powder on medical gloves,” reads one comment submitted by concerned citizen Julie A. Garrison.

The use of powdered medical gloves has been an ongoing debate in the medical field for nearly two decades. Citizen.org documents a case dating all the way back to 1998 where a public citizen, who was also a medical doctor and professor of medicine at the time, petitioned the FDA to ban medical gloves containing cornstarch powder. Cornstarch is the most commonly used powder for lubricating medical gloves, but does not easily absorb into natural latex.

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Current sterilization techniques cause the starch molecules to remain fully intact and even less absorbable. According to Infection Control Today, these small, fully intact, smooth, round starch molecules float through the air, causing occupational asthma and foreign body reactions inside open wounds. Cornstarch powder can also cause irritant dermatitis and other allergic reactions, but the FDA rejected the 1998 petition, and since that time, have received two more petitions urging the FDA to ban the use of medical gloves containing cornstarch powder.

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Newsweek reported on Monday that the FDA is finally taking a proactive approach and addressing citizen concerns regarding the use of powdered medical gloves, saying the FDA reviewed existing comments and concluded that powdered medical gloves, both latex and synthetic, are indeed detrimental for a number of reasons. The FDA also concluded that a ban on existing medical gloves would not cause a glove shortage at medical facilities or have a serious impact on the economy.

“This ban is about protecting patients and healthcare professionals from a danger they might not even be aware of. We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

Health care facilities can continue using non-powdered natural latex gloves, as well as non-powdered synthetic latex, neoprene, and vinyl gloves. Since cornstarch powder does prove to make donning a latex glove easier, research laboratories are looking into developing an alternative donning agent that would provide the same amount of lubricant, comfort, and protective barrier without the serious health problems associated with cornstarch powder.

For the next 90 days, public comments will be accepted on the Regulations.gov website via another public document posted on Tuesday regarding the recent proposed FDA ban on medical gloves containing cornstarch powder.

[Image by Nadina Wiórkiewicz/Wikimedia Commons]