Medical glove industry unfazed by FDA standard

ERJ staff report (R&PN)

Washington DC -- Manufacturers of rubber medical gloves have given their approval to stringent new testing standards that have caused a spike in the number of imported gloves the US Food and Drug Administration has refused to allow in the US.

According to the final FDA rules handed down in December, the acceptable quality level for examination gloves is now 2.5 defects per 100 pieces, down from the AQL of four allowed since FDA glove testing began in 1990. For surgical gloves, the AQL is now 1.5, down from the previous 2.5.

FDA charts show the agency rejected some 25 containers of imported examination gloves in the month the new testing rule went into effect, compared with fewer than 20 in November and only two in October. While this has created some temporary glove shortages in the US market, reputable glove manufacturers and importers welcome the tighter standards, according to a spokesman for Cleveland-based Tradex International.

“This is a true way to differentiate professionals in the marketplace from those with no glove knowledge at all,” the spokesman said. “It created some challenges in the marketplace, but it fulfills a need for a better, safer glove.”

From Rubber & Plastics News (A Crain publication)