Washington \u2014 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.<\/p>\n
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.<\/p>\n
\u201cAnsell 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,\u201d Ansell said in a statement.<\/p>\n
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.<\/p>\n
\u201cWhile 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,\u201d the agency said.<\/p>\n
Powder makes it easier to put on latex gloves or take them off, but that benefit is greatly outweighed by its dangers, FDA said.<\/p>\n
\u201cIn particular, aerosolized glove powder on natural rubber latex gloves, but not on synthetic powdered gloves, can carry proteins that may cause respiratory allergic reactions,\u201d the agency said.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
\u201cThe ban is also not likely to impact medical practice, because many non-powdered protective glove options are currently available,\u201d it said.<\/p>\n
Powdered radiographic protection gloves would be exempt from the proposed rule, largely because they are no longer on the market, according to FDA.<\/p>\n
Consumer safety group Public Citizen first petitioned FDA for a ban on powdered gloves in 1998, and it petitioned it again in 2011.<\/p>\n
\u201cThe fact that it took the FDA 18 years to propose banning powdered surgical gloves from the market highlights how recklessly negligent the agency is,\u201d Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, said in a statement. \u201cThere is absolutely no new scientific information today that we didn’t have in 1998.\u201d<\/p>\n
There have long been plenty of alternatives to powdered gloves, according to Wolfe. \u201cEven in 1998, a quarter of all surgical gloves were powder-free,\u201d he said.<\/p>\n
Meanwhile, medical glove manufacturers made it plain they are concentrating on non-powdered gloves.<\/p>\n
\u201cWe don’t do much in the way of powdered gloves, especially powdered examination gloves,\u201d said Dave Shutt, director of product management at Showa Best. \u201cWe promote our examination gloves as powder-free.\u201d<\/p>\n
Lim Cheong Guan, executive director of Top Glove, also said his company is unconcerned about the FDA proposal.<\/p>\n
\u201cWe do not expect a significant impact from this move, as the powdered gloves we export to the U.S. are for non-medical use,\u201d he said. \u201cHowever, 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.\u201d<\/p>\n
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.<\/p>\n
\u201cAnsell 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,\u201d he said.<\/p>\n
The proposed rule appeared in the March 22 Federal Register.<\/p>\n","protected":false},"excerpt":{"rendered":"
Washington \u2014 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 […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"","nova_meta_subtitle":"","footnotes":""},"categories":[5572],"tags":[],"supplier":[2713],"class_list":["post-34294","post","type-post","status-publish","format-standard","hentry","category-bio-based","supplier-us-food-and-drug-administration-fda"],"_links":{"self":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts\/34294","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/comments?post=34294"}],"version-history":[{"count":0,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts\/34294\/revisions"}],"wp:attachment":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/media?parent=34294"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/categories?post=34294"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/tags?post=34294"},{"taxonomy":"supplier","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/supplier?post=34294"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}