On December 19, 2016, the Center for Devices and Radiological Health at the U.S. Food and Drug Administration issued a final rule banning all powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgical gloves intended for use by humans because these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by a change in labeling.
The FDA’s Center for Veterinary Medicine is issuing this update to ensure that veterinary stakeholders are aware that the ban applies to all powdered medical gloves used by humans except powdered radiographic protection gloves, including powdered medical gloves used in the practice of veterinary medicine.
This ban is effective January 18, 2017, for any devices intended for use by humans that are in commercial distribution and for any devices already sold to the ultimate user. This means that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgical gloves that have already been sold to or are already in the possession of end users, including veterinary clinics and animal surgical centers, are subject to the ban. The FDA advises stakeholders and institutions to dispose of pre-existing supplies of powdered medical gloves in accordance with standard industry practices and established procedures of the local community’s solid waste management system.
Non-powdered alternatives for surgeon’s and patient examination gloves are available and offer the same level of protection, dexterity, and performance as powdered gloves without carrying the risks associated with powdered gloves.
Affected stakeholders with questions about the ban can contact Michael Ryan from the Center for Devices and Radiological Health by emailing Michael.Ryan@fda.hhs.gov.