April 2007

Manufacturers respond positively to FDA’s move to tighten acceptable quality levels for manufacturing
of surgeon and exam gloves

In an effort to reduce the risk of transmission of blood-borne pathogens (particularly human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infections), the Food and Drug Administration earlier this year issued a correction to the final regulation that appeared in the Federal Register of December 19, 2006 (71 FR 75865). The document issued a final regulation that improves the barrier quality of medical gloves marketed in the United States. The rule accomplishes this by ensuring that medical gloves (surgeons’ and patient examination gloves) maintain a high level of quality with respect to the level of noted defects.

The rule reduces the current acceptable quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves. The previous AQL (being replaced by this rule) for medical gloves allowed a defect rate of 4.0 percent for patient examination gloves and 2.5 percent for surgeons’ gloves. The AQL represents the proportion of sampled gloves from a given lot that may include defects such as leaks or foreign material and still be accepted for entry into the marketplace. Currently, if more than 4 percent of the sampled patient examination gloves exhibit defects in accordance with the sampling criteria, the entire lot of gloves is considered adulterated. Surgeons’ gloves are sampled to a higher quality level (lower AQL requires a higher proportion of non-defective gloves in order to pass inspection), because these products have a higher likelihood of contact with bodily fluids. 

The FDA ruled that, effective December 19, 2008, the new FDA maximum AQL for exam gloves will be lowered from 4.0 percent to 2.5 percent, while the maximum AQL for surgical gloves will be reduced from 2.5 to 1.5 percent. Most if not all of the country’s major glove manufacturers, including Ansell Healthcare, Kimberly Clark Health Care, Cardinal Health, Medline Industries, Tronex Healthcare Industries and Molnlycke Health Care, have complied with the new higher standards for some time now.  

“We are pleased by the FDA’s move to tighten quality standards for exam gloves from 4.0 to 2.5 AQL (Acceptable Quality Level),” said David Parks, general manager, global business management, Kimberly-Clark Health Care. “Kimberly-Clark’s gloves have always exceeded industry guidelines for AQL testing by consistently delivering product quality at 1.5 AQL. Even after implementation of this final FDA rule, our exam glove products will be produced to a higher standard than what it specifies.”

“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.  

“By tightening the current Acceptable Quality Levels, the gloves coming into the U.S. will have fewer barrier defects, pinholes, leaks, etc. As it has historically done, Medline will continue to exceed even the new FDA guidelines,” said Tripp Amdur, president, Medline Gloves Division.

To read the final rule CLICK HERE.