FDA Proposes Ban on Powdered Medical Gloves

The FDA is eyeing a ban on most powdered gloves in the U.S., as the agency says they pose unreasonable and substantial risks that cannot be corrected through new or updated labeling.

If finalized, the ban ― which the agency has recommended in a proposed rule ― would apply to powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove.

The proposal follows a request for comments in Draft Guidance for Industry and FDA Staff: Recommended Warning for Surgeon’s Gloves and Patient Examination Gloves that Use Powder, which was issued in February 2011.

That document proposed a general voluntary warning; however, as agency officials reviewed the comments received, they determined that a ban on powdered gloves is appropriate and decided not to finalize the draft guidance. Last May, the FDA withdrew the draft guidance as part of an effort to remove documents issued before 2014 that had not been finalized.

The ban is a long time in coming, at least according to Public Citizen. In 1998, the consumer group submitted a citizen petition requesting a ban on the use of cornstarch powder in the manufacture of latex surgeon and patient examination gloves. The agency denied the petition.

“The fact that it took the FDA 18 years to propose banning powdered surgical gloves from the market highlights how recklessly negligent the agency is,” says Sidney Wolfe, founder and senior adviser of Public Citizen’s health research group.

The FDA acknowledges that scientific evidence in 1998 indicated glove powder was associated with negative health consequences. However, certain factors weighed against removing the devices from the market at the time, including quality concerns, the lack of suitable alternatives and costs.

Between 2008 and 2011, the FDA received three petitions seeking a ban on the use of cornstarch powder on natural rubber latex and synthetic latex surgical and examination gloves. The petitions, including one from Public Citizen in 2011, prompted the agency to evaluate new data on the risks of using powdered gloves and consider new information on alternatives.

The FDA says it conducted an economic analysis showing a powdered glove ban would not lead to a shortage, and the economic impact of a ban would not be significant.

The ban also probably wouldn’t affect medical practice, as there are many non-powdered protective glove options available.

Non-powdered surgeon gloves and non-powdered patient examination gloves will remain Class I devices.

Comments are due June 20. Read the proposed rule here: www.fdanews.com/03-21-16-FDAGloves.pdf. — Jonathon Shacat