FDA guidance on glove lubrication PMAs (Pre-market Approvals):
This article was originally published in Clinica
Executive Summary
The US FDA has issued a new final guidance document on what should be in a premarket approval application for absorbable powder used to lubricate surgical gloves. The information had previously been inappropriately included as part of a special control for class II gloves and is now being pulled out as part of a stand alone document, the agency announced in an April 13 Federal Register notice.
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