New FDA standards governing the reliability of disposable medical and surgical gloves take effect December 19, designed to reduce the risk of transmission of blood-borne pathogens.

These new FDA standards:

- Apply only to medical and surgical grade gloves, and measure only for defects, not for phyiscal properties such as tensile strength or elongation
- Harmonize FDA and ASTM standards, although the FDA standards includes testing for visual defects at the same AQL level as for pinhole defects
- Lower AQL levels for medical and surgical grade gloves to 2.5 and 1.5, respectively.

These new standards have already increased costs and created shortages in medical gloves. Because even one failed FDA inspection can place a manufacturer in detention, most reputable manufacturers were already producing gloves to stricter standards. Now, with new FDA standards taking effect, manufacturers will be forced once again to adopt practices to ensure their gloves exceed even these newest standards. With these changes comes additional costs in materials, process, and inspection–all of which are being passed directly to suppliers.

At the same time, suppliers dependent on less reputable manufacturers are now frantically in search of product, as these manufactuers fail to meet the stricter standards. With less supply, competition continues to drive prices upward as suppliers compete to secure product.

See Also:
New FDA Medical Glove Standards
FDA Dention Policy
FDA Medical Glove Guidance Manual