FDA Ban on Powdered Gloves
Sudha Kamada
FDA Ban on Powdered Gloves
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 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, after the ban was proposed..

Powdered Gloves Ban
Specifically, FDA says it will ban the sale, distribution and manufacturing of all powdered surgeon's gloves, powdered patient examination gloves and absorbable powder used to lubricate surgeon's gloves, though it notes the ban will not apply to powdered radiographic protection gloves.

Additionally, the ban will not apply to powder used during the manufacturing process for non-powdered gloves, so long as only trace amounts (no more than 2mg of powder per glove) make it into the finished product.

To facilitate the ban, FDA says it is also amending the classification regulations for medical gloves in order to distinguish between powdered and non-powdered gloves, as the current classifications do not differentiate between the two.


- See more at: http://www.raps.org/Regulatory-Focus/News/2016/12/16/26391/FDA-Bans-Powdered-Gloves/#sthash.knJQzery.dpuf

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