Say Goodbye to Powdered Gloves: FDA Ban Coming in January

December 30, 2016 | Aging Services Risk, Quality, & Safety Guidance

Preview

​The U.S. Food and Drug Administration (FDA) announced on December 19, 2016, that it is banning all powdered medical gloves (except powdered radiographic protection gloves) and absorbable powder for lubricating gloves beginning on January 18, 2017. These devices pose an "unreasonable and substantial" risk of injury and illness to both patients and providers that cannot be corrected by labeling changes, FDA said. The risks are severe airway inflammation, hypersensitivity reactions, and formation of granulomas or adhesions, after internal tissue is exposed to the powder. After a review, FDA said banning these devices would have minimal economic impact and would not lead to a shortage. In fact, FDA said, due to the reduction of adverse events that would come from banning the gloves, net savings could be from $26.8 million to $31.8 million.

Access Full Content

Contact us today at 610.825.6000.