Categories
Announcements Compliance, Integrity & Safety

Research Insights

Powdered Surgeon’s Gloves Banned for Research and Clinical Practice, Including Veterinary Medicine

The Food and Drug Administration (FDA or Agency) has 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 Food and Drug Administration (FDA or Agency) has 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 ban, effective Jan. 18, 2017, applies to all powdered medical gloves regardless of application (medical, research, etc.) used by humans except powdered radiographic protection gloves. The ban includes powdered medical gloves used in the practice of veterinary medicine. It includes gloves powdered with cornstarch and talcum powder.

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.