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…

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