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  • Regulatory NewsRegulatory News

    FDA Bans Powdered Gloves

    The US Food and Drug Administration (FDA) on Friday issued a final rule banning powdered medical gloves beginning on 19 January 2017. FDA proposed the ban in March, citing mounting evidence that such gloves posed serious risks to patients, including airway and wound inflammation, post-surgical adhesions and allergic reactions. This is only the second time FDA has banned a medical device since banning prosthetic hair fibers in 1983. In April, FDA proposed banning a ...
  • Regulatory NewsRegulatory News

    FDA Seeks Ban on Powdered Medical Gloves

    The US Food and Drug Administration (FDA) on Monday announced its intent to ban the use of most powdered medical gloves, citing an "unreasonable and substantial risk" to patient health. "This ban is about protecting patients and health care professionals from a danger they might not even be aware of," said Jeffrey Shuren, director of the Center for Devices and Radiological Health. The proposed ban would apply to all powdered surgeon's gloves, powdered patient examinatio...
  • Regulatory NewsRegulatory News

    FDA Cracks Down on Powdered Caffeine Distributors

    The US Food and Drug Administration (FDA) issued five warning letters to distributors of pure powdered caffeine as part of its efforts to help prevent additional deaths from the use of these products, which have already resulted in the deaths of two teens. "The difference between a safe amount and a toxic dose of caffeine in these pure powdered products is very small," FDA  cautioned . "Furthermore, safe quantities of these products can be nearly impossible to measure ac...