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Cardinal Health Complies with New FDA Glove Rule Two Years Ahead of Deadline
02/01/2007

McGAW PARK, Ill., February 1, 2007 – Cardinal Health, the leading provider of products and services supporting the health-care industry, today announced the medical gloves it manufactures already meet or exceed new barrier standards from the Food and Drug Administration (FDA) that are set to go into effect on Dec. 19, 2008.

 

 

The FDA recently revised its ruling to improve the barrier quality of medical gloves marketed in the United States. The rule will accomplish this by tightening current acceptable quality levels (AQLs) for leaks and visual defects observed during the random FDA testing of medical gloves. The new FDA ruling will establish the AQL of 1.5 for surgical gloves and 2.5 for exam gloves. Gloves with a lower AQL have fewer barrier defects, or pinholes. The move will harmonize the FDA AQLs with consensus standards developed by other organizations and the European Community.

 

Gloves made by Cardinal Health have always exceeded industry test standards. The company sets its internal standards to be more stringent than both ASTM and FDA requirements, meaning its gloves already comply with the new rule nearly two years before the deadline. 

 

“We are very supportive of the FDA’s new rule, which is in line with industry standards,” said Dennis Streppa, Cardinal Health’s vice president and general manager of gloves. “In the more than 40 years we've been manufacturing exam and surgical gloves, we've always had more stringent standards than required and have never settled for less than the highest standard of quality.”

 

Cardinal Health invests in research and technological innovations to meet the needs of health-care providers and their patients. For four decades, the company has been offering the most extensive, highest quality and technologically advanced lines of medical gloves.

 

In addition to the Esteem® polyisoprene surgical gloves, the company offers Kashmere™ and Protegrity® brands of powder-free latex surgical gloves, made with an advanced triple-dip bonding technology. Cardinal Health also offers a complete line of latex and synthetic examination gloves to meet the needs of health-care professionals in the lab, physician's office, hospital and other health-care settings.

 

 

About Cardinal Health

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is an $81 billion, global company serving the health-care industry with a broad portfolio of products and services. Through its diverse offerings, Cardinal Health delivers health-care solutions that help customers reduce their costs, improve safety and productivity, and deliver better care to patients. The company manufactures, packages and distributes pharmaceuticals and medical supplies, offers a range of clinical services and develops automation products that improve the management and delivery of supplies and medication for hospitals, physician offices and pharmacies. Ranked No. 19 on the Fortune 500, Cardinal Health employs more than 55,000 people on six continents. More information about the company may be found at www.cardinalhealth.com.

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