Glove makers put powder on gloves as a lubricant to make donning the gloves easier. However, according to the FDA, when internal body tissue is exposed to the powder, it can case severe airway inflammation and hypersensitivity reactions. Additionally, powder particles can trigger an immune response, causing tissue to form around the particles, which can complicate surgeries.
“[T]he risk of illness or injury posed by powdered gloves is unreasonable and substantial,” reads the FDA’s final rule.
The ban, covering powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove, will go into effect Jan. 18. The FDA does not expect the ban to cause a glove shortage in the industry.
Read the full final rule here.
The FDA has only banned one other medical device in its history. Prosthetic hair fibers have been banned since 1983, since they did not stimulate hair growth and could instead cause serious infections, illnesses and injuries.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.