07/02/2017
On December 19, 2016, the FDA published a final rule banning powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves. The risks to both patients and health care providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body’s immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesions) which can lead to surgical complications.
For a detailed description of the risks that the FDA identified, please refer to the final rule. There are other surgical and patient examination gloves available that provide the same level of protection, dexterity, and performance without posing the same risks to patients and health care providers.
The final ban is effective for powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove that are already in commercial distribution and for these devices that are already sold to the ultimate user, such as small medical practices and hospitals, on January 18, 2017.
For more information, please check with the offical website http://www.fda.gov/MedicalDevices/Safety/MedicalDeviceBans/default.htm
The FDA has the authority to ban a medical device intended for human use if it finds, on the basis of all available data and information, that the device presents a substantial deception to patients or users about the benefits of the device, or an unreasonable and substantial risk of illness or inju...
