Washington — Latex glove manufacturers reacted calmly to the Food and Drug Administration's proposed rule banning most powdered medical gloves for sale or distribution in the United States.
Major manufacturers already are moving quickly away from powdered gloves and actively promoting powder-free gloves as a way of preventing asthma, latex allergies and other severe complications of exposure to powder, according to spokespersons for Ansell Ltd., Top Glove Corp. Bhd. and Showa Best Gloves Inc.
“Ansell recommends those involved in health and safety policy decisions to convert their organizations from powdered to powder-free, low-protein latex or synthetic gloves as an effective method of reducing both patient complications associated with powdered gloves and the incidence of asthma and latex allergy in health care providers,” Ansell said in a statement.
In a March 21 news release, FDA said it intends to ban powdered surgical gloves, powdered patient examination gloves and absorbable powder for lubricating surgical gloves.
“While 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,” the agency said.
Powder makes it easier to put on latex gloves or take them off, but that benefit is greatly outweighed by its dangers, FDA said.
“In particular, aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions,” the agency said.
But powdered synthetic gloves, along with powdered latex gloves, also present risk of severe airway inflammation, wound inflammation, post-surgical adhesions and other problems, it said.
In writing the proposed rule, FDA said, it reviewed the voluminous scientific evidence on the effects of powder, as well as the 285 comments it received in response to a February 2011 Federal Register notice calling for comments on adverse reactions to powdered gloves.
Also, the agency said it conducted an economic analysis that showed a ban on powdered gloves neither would cause a glove shortage nor have a significant economic impact on the medical glove industry.
“The ban is also not likely to impact medical practice, because many non-powdered protective glove options are currently available,” it said.
Powdered radiographic protection gloves would be exempt from the proposed rule, largely because they are no longer on the market, according to FDA.
Consumer safety group Public Citizen first petitioned FDA for a ban on powdered gloves in 1998, and it petitioned it again in 2011.
“The fact that it took the FDA 18 years to propose banning powdered surgical gloves from the market highlights how recklessly negligent the agency is,” Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement. “There is absolutely no new scientific information today that we didn't have in 1998.”
There have long been plenty of alternatives to powdered gloves, according to Wolfe. “Even in 1998, a quarter of all surgical gloves were powder-free,” he said.
Meanwhile, medical glove manufacturers made it plain they are concentrating on non-powdered gloves.
“We don't do much in the way of powdered gloves, especially powdered examination gloves,” said Dave Shutt, director of product management at Showa Best. “We promote our examination gloves as powder-free.”
Lim Cheong Guan, executive director of Top Glove, also said his company is unconcerned about the FDA proposal.
“We do not expect a significant impact from this move, as the powdered gloves we export to the U.S. are for non-medical use,” he said. “However, should our customers decide to switch to powder-free gloves or nitrile gloves, we are able to accommodate this, as we have the production capacity to do so.”
The Ansell spokesman said his company has conducted extensive research on latex allergies since 1992. Its research, he said, has shown that aerosolized glove powder spreads not only latex antigens but also opportunistic and pathogenic micro-organisms.
“Ansell offers many comfortable powder-free glove styles with advanced technology and coatings, allowing the user to easily don the glove while enhancing patient and health care provider safety,” he said.
The proposed rule appeared in the March 22 Federal Register.