martes, 22 de marzo de 2016

Proposal to Ban Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove

While medical gloves play a significant role in protecting patients, health care providers and other individuals in close proximity, the powder used on some gloves has been proven to cause serious injury. Risks include respiratory allergic reactions, lung inflammation, post-surgical adhesions and possibly death. The FDA has determined that use of these gloves and glove powder is dangerous and presents unreasonable and substantial risk that cannot be corrected through new or updated labeling.
Comments to the proposed rule can be submitted to the docket until June 20, 2016.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health

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