
The reason: FDA concluded these products "present unreasonable and substantial risk to healthcare providers, patients and other individuals."
FDA noted that powdered gloves are "very dangerous" for a few reasons:
- They are associated with potentially serious adverse events, including severe airway inflammation, hypersensitivity reactions, allergic reactions, lung inflammation and damage or post-surgical bands of fibrous scar tissue that form between internal organs and tissues.
- Aerosolized glove powder can carry proteins that may cause respiratory allergic reactions.
FDA concluded that a transition to non-powdered alternatives should provide similar protection, dexterity and performance that powdered gloves do, without the risks associated with powder.
This is only the second instance of an FDA ban of a device. The first was prosthetic hair fibers in 1983.