The US Food and Drug Administration (FDA) has issued a final rule to ban powdered surgical gloves, patient examination gloves and the absorbable powder used to lubricate surgical gloves.
Citing associations with serious adverse events—including allergic reactions, lung and airway inflammation and post-surgical bands of fibrous scar tissue that can present between internal organs and tissues, among others— the agency states that powdered gloves “present unreasonable and substantial risk to health care providers, patients and other individuals.
Given the availability of non-powdered gloves which can “provide similar protection, dexterity and performance” without the risks associated with powder, the FDA states that, “a transition to alternatives in the marketplace should not result in any detriment to public health.”
The FDA has only banned one other medical device in its 110-year history. The agency banned prosthetic hair fibres for hair transplantation in June 1983.
