July 10, 2020

Why are Powdered Nitrile Gloves Banned in the USA For Medical Examination Purposes?

 

There is a very good reason that powdered Nitrile Gloves should not be allowed to touch exposed tissue especially in healthcare settings.

On December 19, 2016, the FDA published a final rule banning powdered gloves based on the unreasonable and substantial risk of illness or injury to individuals exposed to the powdered gloves. The risks to both patients and health care providers when internal body tissue is exposed to the powder include severe airway inflammation and hypersensitivity reactions. Powder particles may also trigger the body’s immune response, causing tissue to form around the particles (granulomas) or scar tissue formation (adhesions) which can lead to surgical complications. For a detailed description of the risks that the FDA identified, please refer to the document (FDA Ruling on 19 December 2016) Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove

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