Tr@ce gloves both new and reprocessed, are cleaner than any new conventional disposable exam gloves, where multiple studies have shown them to contain significant levels of microbiological contamination.

They are also much safer because of individual testing for pin holes that is not done by any other supplier.

Since January 2009 the FDA’s standard for pinholes has been reduced from an AQL of 4 to 2.5, emphasizing the importance that is attached to this aspect. The application of this rule has caused a jump of 1200% of rejected containers after FDA control at the USA borders.

Except for some of the leading glove makers, that self-assess the bioburden level of risk in accordance with FDA guidelines, almost all the other single-use exam gloves present on the market are not subject to any microbiological contamination QA control and represent a real risk of cross-contamination, accidental or intentional contamination.

In 1999, the FDA aware of the potential quality and risk issues on medical glove proposed “the reclassification of surgeon's and patient examination gloves from Class I to Class II, because general controls are insufficient to assure their safety and effectiveness. The proposed Class II glove types are:

• powdered surgeon's gloves
• powder-free surgeon's gloves
• powdered patient examination gloves
• powder-free examination gloves
(document link)

The FDA proposal could not, however, for various reasons, however In December 2008, the AQL for exam gloves will be tightened from 4 to 2.5 while in Europe the AQL is at 1.5

This indicates that the regulatory bodies worldwide are embarking into a tightning of the quality standard.

Tr@ce gloves stand at the forefront of this latent trend.