Med Device Monday: FDA's Rare Ban on Powdered Gloves

From the outside, it can be easy for some to mistake FDA's abundance of caution for bureaucratic red tape. In truth, FDA is exceptionally careful in their process for reviewing and approving (or not approving) medical devices. This abundance of caution is why bans on approved devices are so rare. In fact, FDA's recent ban on powdered gloves is only the second ban they've ever issued. (The first one was for synthetic hair fibers in 1983.)

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Per the final rule, which is effective beginning January 18, 2017, "The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices...Medical gloves play a significant role in the protection of both patients and health care personnel in the United States. Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when conducting more limited interactions with patients. Various types of powder have been used to lubricate gloves so that wearers could don the gloves more easily. However, the use of powder on medical gloves presents numerous risks to patients and health care workers, including inflammation, granulomas, and respiratory allergic reactions."

FDA proposed the ban in March of 2016, stating "“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health. “We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

Powder is sometimes added to gloves to help make it easier to put them on and take them off; however, powdered gloves are dangerous for a variety of reasons. In particular, aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions. Although powdered synthetic gloves do not present the risk of allergic reactions, these devices are associated with an extensive list of potentially serious adverse events, including severe airway inflammation, wound inflammation, and post-surgical adhesions, which are bands of fibrous scar tissue that form between internal organs and tissues. These side effects have been attributed to the use of glove powder with all types of gloves."

FDA goes on to explain that in addition to protecting health, it should be reasonably easy to make the change to non-powdered gloves because alternatives are already widely available on the market. The ban applies to powdered patient examination gloves, powdered surgical gloves, and absorbable powders used to lubricate surgical gloves. The ban is specific to these instances, and doesn't apply to any other powders or use of powders in medical devices, such as condoms, because the same risks are not posed. In previous regulations, FDA has not distinguished between powdered and non-powdered gloves previously but will do so going forth.

RAPS points out that this ban is not a new idea, saying "...Michael Carome, director of Public Citzien's [sic] Health Research Group, criticized the agency for how long it took to issue the ban. Public Citizen has twice called for FDA to ban powdered gloves, first in 1998 and again in 2011."

You can read a bit about the history of gloves on this glove manufacturer's website. Carome also explains on the Citizen website, "Medical gloves have played a crucial role in protecting both patients and health care providers for more than a hundred years. In particular, they act as barriers against transmission of infections between health care workers and patients during surgery and patient examinations. 

The first medical gloves were made from natural latex rubber obtained from latex-producing trees. Nonlatex medical gloves made from synthetic materials have become increasingly available over the past few decades. 

Since the late 19th century, various powders have been used to lubricate gloves so physicians can don them more easily.[1] The first powders used were composed of spores from a type of evergreen plant called lycopodium or club moss. By the 1930s, the powders made from club moss spores had been found to cause inflammation and scar tissue formation in surgical wounds. Talcum powder was subsequently used as a glove powder, but in the 1940s it too was linked to these same adverse reactions. 

In 1947, cornstarch powder was introduced as a glove powder, and by the 1970s it had largely replaced talc as a lubricant for surgical gloves."

In short, this ban has, as with any FDA decision, been carefully considered. The final rule has a lot of interesting information and if you have the time I'd recommend reading it. They address the reasons for the ban, implications, and comments they received both for and against the ban. 

Further reading:

Medscape's article on the ban

Med Device Online's article on the ban