The Food and Drug Administration (“FDA”) has proposed a ban of most powdered medical gloves in the U.S., saying that the use of these gloves “pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them.”
The ban would apply to powdered gloves used in patient examinations and surgery. It would not apply to powdered radiographic protection gloves, since the FDA said it was not aware of any that are currently on the market.
The FDA said the ban action was necessary in order to protect the public health, and that powdered medical gloves “are dangerous and present an unreasonable and substantial risk.”
Powder can be added to medical gloves to make them easier to put on and remove. According to the FDA, aerosol glove powder used on natural rubber latex gloves can cause respiratory allergic reactions. Powdered synthetic gloves do not carry the same allergy risks, but can cause inflammation of the airway and wounds.
In addition, the FDA said that powdered medical gloves have been shown to increase the incidence of post-surgical adhesions, causing bands of scar tissue to form between tissues and internal organs.
The FDA said that since these adverse events could not be cured by warning labels, it was moving to ban the use of powdered medical gloves altogether. As part of its decision-making process, the agency said it also considered the economic impact of such a ban and found it would not be significant. The FDA also said the ban would not lead to a medical glove shortage, since there are many non-powdered medical gloves on the market.
If you have suffered injuries from an unsafe or defective medical product, the experienced product liability legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.