The US Food and Drug Administration (FDA) published a final rule banning powdered examination gloves, powdered surgeon’s gloves, and absorbable powder for lubricating a surgeon’s glove. This rule does not cover or include powdered radiographic gloves. The FDA placed the ban on the above medical device due to unreasonable and substantial risks to individuals exposed to powdered gloves including patients and health care providers. The risks when internal body tissues are exposed to this powder include severe airway inflammation and hypersensitivity reactions. Surgical complications could occur in circumstances where the powder particles cause an immune response thus creating granulomas and adhesions. Additionally, other surgical and examination gloves are available as alternatives which provide the same level of defense, agility, and function without posing these risks to either party.
The FDA, according to the Federal Food, Drug and Cosmetic Act, has the authority to ban a medical device intended for human usage should it find the device based on all available data to pose substantial deception to patients or users about the benefits of the device, or an unreasonable and substantial risk of illness or injury, which cannot be remedied or improved by the labeling. Until 2016, the FDA has banned only one other medical device, which was prosthetic hair fibers in 1983, upon determination that this device held no health benefit to the public. In fact, the devices were found to be marketed in such a way that was deceptive to patients and posed a sizable health risk.
The final ban for powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubrication of a surgeon’s gloves that are already in commercial distribution and for these devices that are already sold to the ultimate user, for example, individual medical groups and hospitals will become effective January 19, 2017.