FDA Finalizes Ban on Powdered Surgeon Gloves, Citing Potential for 'Substantial Risks'

The U.S. Food & Drug Administration (FDA) has announced it is finalizing its ban on powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove.

The reason: FDA concluded these products "present unreasonable and substantial risk to healthcare providers, patients and other individuals."

FDA noted that powdered gloves are "very dangerous" for a few reasons:

• They are associated with potentially serious adverse events, including severe airway inflammation, hypersensitivity reactions, allergic reactions, lung inflammation and damage or post-surgical bands of fibrous scar tissue that form between internal organs and tissues. 
• Aerosolized glove powder can carry proteins that may cause respiratory allergic reactions.

FDA concluded that a transition to non-powdered alternatives should provide similar protection, dexterity and performance that powdered gloves do, without the risks associated with powder. 

This is only the second instance of an FDA ban of a device. The first was prosthetic hair fibers in 1983.