FDA Bans Powdered Gloves
The FDA first identified powdered gloves as a potential risk to patients in 1997, determining at the time that airborne glove powder represented a threat to individuals allergic to natural rubber latex. In addition, FDA felt airborne glove powder could represent an important agent for sensitizing non-allergic individuals. At the time, however, the FDA refrained from issuing a full-scale ban, in part because they believed there were not sufficient adequate alternatives to powdered gloves in the marketplace.In early 2017, the Food and Drug Administration (FDA) issued the following statement:
The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.
The FDA’s final rule bans powdered surgeon's gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon's glove. Because FDA classification regulations do not distinguish between powdered and non-powdered versions, the agency will amend the descriptions of these gloves to specify that the regulations for patient examination and surgeon's gloves will apply only to non-powdered gloves, while the powdered version of each type of glove will be added to the listing of banned devices in the regulations.