Cardinal Health says all its gloves meet new FDA rules

McGaw Park, Illinois -- Cardinal Health said 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 in the United States on from December, 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 harmonise the FDA AQLs with consensus standards developed by other organisations and the European Community.

"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."

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Press release from Cardinal Health