FDA Proposes Ban on Powdered Medical Gloves
08 April 2016
The Food and Drug Administration is proposing to ban powdered surgeon’s gloves, powdered patient examination gloves and absorbable powder for lubricating a surgeon’s glove after having determined that these goods present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labelling or a change in labelling. The FDA has determined that this ban should apply to such goods already in commercial distribution or sold to the ultimate user as well as those that would be sold or distributed in the future. Comments on this proposal are due by 20 June.
The proposed ban would not apply to the non-powdered versions of the above types of gloves, powder used in the manufacturing process of non-powdered gloves where that powder is not intended to be part of the final finished gloves, or powder intended for use in or on other medical devices.
- Medical Supplies & Medicine
- North America