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FDA Bans Powdered Gloves

FDA Bans Powdered Gloves

 The U.S. Food and Drug Administration (FDA) has announced a ban on most powdered gloves used in the medical space citing “an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling”.  The ‘go-live’ date for this new rule is January 18, 2017

 Specifically, the FDA investigation found that proteins, carried in the powder, can produce respiratory allergic reactions, severe airway inflammation, wound inflammation and post-surgical adhesions. In a Medscape report, details regarding the potential health impact on patients from powdered gloves included:  hypersensitivity reactions, allergic reactions (including asthma), lung inflammation and damage, granulomas, and peritoneal adhesions. 

The original reason for putting powder on gloves was to make it easier for the medical practitioner to put the gloves on.  But according to Surgical Products Magazine, new technology has produced gloves that are much easier to don and do not require the powder.

The impact of the FDA ban on the overall market for medical gloves should be minimal. The FDA reports that the market share of powdered gloves has been dropping significantly in recent years.


Happy New Year!


Medscape Article: http://www.medscape.com/viewarticle/873394

FDA News Release: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491466.htm

Rule PDF from the Federal Register: https://www.gpo.gov/fdsys/pkg/FR-2016-12-19/pdf/2016-30382.pdf

Surgical Products Magazine: http://www.surgicalproductsmag.com/news/2016/12/years-after-first-identifying-risk-fda-bans-powdered-gloves-medical-settings