The U.S. FDA recently announced a proposal to ban the use of powdered gloves in healthcare facilities.
- Medical gloves are available as either powdered or non-powdered kind.
- FDA has proposed a ban on powdered surgeon and patient examination gloves. The ban also applies to the absorbable powder used for lubricating surgeon’s gloves.
Before making this proposal, FDA first systematically analyzed available scientific literature on the use of the powdered gloves and the comments received on a February 2011 Federal Register Notice.
The proposed ban includes everything from powdered surgeon’s gloves, powdered patient examination gloves to absorbable powder for lubricating a surgeon’s glove. However, non-powdered surgeon gloves and non-powdered patient examination gloves are exempted from the ban and will continue to be Class I medical devices.
Studies have shown that unlike the synthetic (non-rubber) powdered gloves, the aerosolized glove powder in natural rubber latex gloves could carry proteins that could potentially cause some respiratory allergic reactions.
Why is It Not Good to Use Glove Powder?
Research studies have demonstrated that the powder used on medical gloves could:- Increase infections
- Cause irritation
- Facilitate foreign body reactions
- Be a carrier of natural latex allergens
- Adhere to peritoneal tissues after surgery leading to possible infection
- Cause respiratory allergic reactions (especially seen with natural rubber latex gloves)
- Cause granuloma and scar formation (especially corn starch)
Side Effects Attributed to the Use of Glove Powder
- Severe airway inflammation
- Wound inflammation
- Post-surgical adhesions (bands of fibrous scar tissue which form in between internal organs and tissues)
FDA is of the opinion that new or updated labeling would not take care of the risks associated with the use of the powdered medical gloves. Hence, they propose to ban the use of these products, which if finalized could eventually remove all of them from the market.
References:
- http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491466
- http://www.gastro.org/news_items/2016/3/22/fda-proposes-ban-on-most-powdered-medical-gloves