Home >  News >  March, 2016

FDA Says Powdered Gloves Have to Go

While use of these gloves is decreasing, agency says they pose an unreasonable and substantial risk of illness or injury.

Published: March 21, 2016

COMPLETE HALT The FDA says the risks associated with powdered gloves can't be corrected through new or updated labeling.

Arguing that they pose an unreasonable and substantial risk of illness or injury, the FDA is finally giving powdered gloves the ultimate thumbs down, proposing a ban on powdered surgeon's gloves, powdered patient examination gloves and absorbable powder for lubricating surgeons' gloves.

"We take bans very seriously and only take this action when we feel it's necessary to protect the public health," says Jeffrey Shuren, MD, the agency's director of Center for Devices and Radiological Health. The risks associated with the gloves can't be corrected through new or updated labeling, says the FDA, defending its call to completely remove them from the marketplace. The economic impact would be insignificant, it says, because many non-powdered gloves are available.

The action comes 5 years after the FDA posted a request for comments and information based on citizen petitions calling for such a ban.

Powder on latex gloves can carry proteins that may cause allergic reactions, and powdered synthetic gloves are associated with an extensive list of health issues, including severe airway inflammation, wound inflammation, and post-surgical adhesions, says the FDA.

Non-powdered surgeon gloves and non-powdered patient examination gloves aren't included in the proposed ban and will remain Class I medical devices.

You'll be able to comment on the proposed ban at www.regulations.gov for the next 90 days.

Jim Burger

Also in the News...

Senator Creates Firestorm With Nurses Playing Cards Comment
Suspect Logged Into Electronic Prescription Program as Ophthalmologist to Fraudulently Issue Opioid Scripts
Marijuana Users May Need Higher Doses of Sedatives Before Endoscopy
Brainlab Recalls Spine & Trauma 3D Navigation 1.0 Software Due to Display Inaccuracies
FDA Orders Withdrawal Of Transvaginal Surgical Mesh From Market
Lawsuit: When PACU Lights Dimmed, Doc Asked Wife to Hold Penlight on Her Husband's Leaking JP Drain
R.I. Smoke Evacuation Legislation Becomes Law

New to Outpatient Surgery Magazine?
Sign-up to continue reading this article.
Register Now
Have an account? Please log in:
Email Address:
  Remember my login on this computer

advertiser banner

Other Articles That May Interest You

Lawsuit: Scrub Nurse Photographed Coworker Nude in OR

Nurse allegedly showed explicit photos to hospital co-workers — and to patient when she returned from medical leave.

Easing the Quality Reporting Burden

Can technology help gather data for CMS quality reporting and benchmarking?

Legal Update: Are You Ready for an Emergency?

Legal nurse consultant: Prepare for a crisis before you have one.