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FDA Proposes Ban on Powdered Medical Gloves

The U.S. Food and Drug Administration has proposed banning powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. Powdered radiographic protection gloves would not be included in the ban. In a March 21 Federal Register notice, FDA stated that, while the level and types of risks from powdered gloves can vary depending on the composition of the glove (synthetic versus latex) and their uses (surgeon’s glove versus patient examination glove), “the risks posed by either of these glove types is unreasonable and substantial in relation to the minimal benefits that powdered gloves offer.”

FDA explained that the powder used for lubricating patient examination and surgeon’s gloves (often referred to as “Absorbable Dusting Powder” or “ADP”) presents risks to the user, the patient, and other exposed individuals. Currently, cornstarch is the most commonly used type of absorbable glove powder. When used on natural rubber latex (NRL) gloves, ADP has the ability to adhere to latex allergenic proteins that, when aerosolized and inhaled, can result in inflammatory responses, hypersensitivity reactions, and allergic reactions. While powdered synthetic gloves do not present the risk of allergic reactions due to aerosolized powder carrying latex as the natural rubber latex gloves, noted the Agency, there is still the risk of exposing individuals to the powder via inhalation and this can lead to airway inflammation. FDA also pointed out that the use of these gloves by health care providers can expose patients' tissues--during surgery and examinations—to deposits of glove powder, which may promote infection or lead to wound healing complications.

FDA first received a citizen petition in 1998 from the nongovernment organization, Public Citizen, requesting that the use of cornstarch powder in the manufacture of latex surgeon’s and patient examination gloves be banned. Between 2008 and 2011, FDA received three more petitions requesting, among other things, that it ban the use of cornstarch powder on NRL and synthetic latex surgical and examination gloves. On February 7, 2011, FDA issued a draft guidance titled, “Draft Guidance for Industry and FDA Staff: Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder,” which proposed a general voluntary warning for powdered gloves.

In announcing the current proposed ban, FDA said that it determined that product labeling or a change in labeling “cannot correct or eliminate the unreasonable and substantial risk of illness or injury” to those who are exposed to powdered medical gloves. If the ban is enacted, powdered gloves currently being used in the marketplace would be subject to the ban. Comments on the proposed ban are due by June 20, 2016.

© 2022 Keller and Heckman LLPNational Law Review, Volume VI, Number 91
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PackagingLaw.com is the premier online resource for the global packaging industry. It provides a wide range of information on laws and regulations—both in the U.S. and other countries throughout the world—that affect packages and packaging materials. PackagingLaw.com features news articles on current issues affecting the packaging industry, in-depth features, an Ask an Attorney section, links to packaging industry and government websites, and detailed information on the U.S. Food and Drug Administration (FDA) Food Contact Notification system.

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