Powdered Medical Gloves Banned by FDA | Bubalo Law PLC
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“Dangerous” Powdered Medical Gloves Banned by FDA

In only the second time in its history, the U. S. Food and Drug Administration (FDA) announced a ban on a medical device deemed too “dangerous” for use. Powdered medical gloves including patient examination gloves, powdered surgeons’ gloves and absorbable powder used to lubricate gloves, will be banned effective January 19, 2017.

The only other FDA ban came in 1983 when it banned prosthetic hair fibers.

The FDA deemed powdered medical gloves “dangerous” because the powder can cause allergic reactions when airborne, create wound inflammation issues, and in some patients, cause scar tissue to develop between their organs.

The FDA announced “While the use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to health care providers, patients and other individuals who are exposed to them, which cannot be corrected through new or updated labeling,” according to an FDA statement in March.

The powder is typically added simply to make medical gloves easier to take on and off, but provides no real medical benefit for the patient, and creates substantial risk for all in the proximity of their use.

The good news is non-powdered medical gloves are available that accomplish sterility goals without the dangerous risks associated with powdered gloves. Fortunately, most healthcare providers already use non-powdered medical gloves so the FDA does not anticipate any shortage of gloves, or problem complying with the ban.

Going forward, the FDA ordered non-powdered medical gloves to have as little powder as possible from the manufacturing process.