Cardinal Health Complies With New FDA Glove Rule Two Years Ahead of Deadline


McGAW PARK, Ill. -- Cardinal Health, a leading provider of products and services supporting the healthcare industry, today announces 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.

Cardinal Health reports that its gloves 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."

In addition to the Esteem(R) polyisoprene surgical gloves, the company offers Kashmere(TM) and Protegrity(R) 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 healthcare professionals in the lab, physician's office, hospital and other healthcare settings.

Source: Cardinal Health, Inc.

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