Here are four key notes:
1. The agency banned powdered surgeons’ gloves, powdered patient examination gloves as well as a powder used to lubricate surgeons’ gloves. The agency did not ban powdered radiographic protection gloves or the powder designated for manufacturing non-powdered gloves.
2. The FDA issued the ban as the gloves and lubricant pose a “substantial risk of illness on injury” and manufacturers cannot correct or get rid of the risk by changing a label.
3. The FDA found medical glove powder may harm patients and providers, causing issues such as inflammation, granulomas and respiratory allergic reactions.
4. After the Federal Register publishes the ban today, Dec. 19, 2016, the rule will go into effect 30 days later.
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At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
