Powdered Medical Glove Allergy Risk Leads FDA to Ban Certain Products

A new rule bans the use of certain powdered medical gloves nationwide, due to concerns that they may cause dangerous allergic reactions for some patients or medical providers. 

The FDA issued the new final rule in the Federal Register on December 19, banning the use of several types of powdered surgical gloves, which federal regulators say may cause enough latex exposure for medical professionals and patients to develop allergies that they may not have otherwise had.

The rule makes it illegal to market powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeon’s gloves. The rule does not affect powdered radiographic gloves, none of which are currently on the market.

“FDA has concluded that the risks posed by powdered gloves, including health care worker and patient sensitization to natural rubber latex (NRL) allergens, surgical complications related to peritoneal adhesions, and other adverse health events not necessarily related to surgery, such as inflammatory responses to glove powder, are important, material, and significant in relation to the benefit to public health from their continued marketing,” the final rule states. “FDA has carefully evaluated the risks and benefits of powdered gloves and the risks and benefits of the state of the art, which includes viable non-powdered alternatives that do not carry any of the risks associated with glove powder, and has determined that the risk of illness or injury posed by powdered gloves is unreasonable and substantial.”

The powder is used to make it easier to put on and remove the gloves, coming in either natural or synthetic versions.

According to the FDA, the natural aerosolized glove powder can carry proteins that cause respiratory allergic reactions. The synthetic powders, while they do not cause allergic reactions, can cause a number of potentially serious adverse events, including:

• Severe airway inflammation
• Wound inflammation
• Post-surgical adhesions

The rule was first proposed in March, and the FDA noted at the time that the use of the gloves was already on the decline. The rule goes into effect on January 18, 2017.

The rule came as the result of a review of scientific literature and comments that followed a 2011 federal register notice. The FDA also noted that the removal of the gloves from the market would not cause a shortage, since there are non-powdered protective gloves available.