FDA today announced it was banning powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon's glove to decrease potential risks to patients and healthcare providers. The final rule, first proposed in March, will be published December 19, and will go into effect 30 days later.
“While medical gloves play a significant role in protecting patients, health care providers and other individuals in close proximity, powdered gloves are very dangerous for a variety of reasons,” the FDA said in its statement.
Powdered gloves present dangerous risks in patient care, including severe airway inflammation, hypersensitivity reactions, allergic reactions, asthma, lung inflammation and adhesions. FDA reports all types of glove powder trigger these adverse effects. They add that the proteins carried in aerosolized glove powder can also cause respiratory allergic reactions.
Because of these risks associated with glove powder, FDA recommends non-powdered alternatives to replace powdered gloves that provide similar protection, dexterity and performance. FDA projects these changes in the marketplace should not impair public health.
FDA has only banned one other medical device in its history: prosthetic hair fibers in June 1983.
For more information: https://www.federalregister.gov/documents/2016/12/19/2016-30382/banned-devices-powdered-surgeons-gloves-powdered-patient-examination-gloves-and-absorbable-powder