FDA Import Alert

FDA Import Alert

Published February 14, 2022

The FDA issued the attached alert this past Friday, February 11th, 2022.

Extract alert:

“CDRH (Center for Devices & Radiological Health) has determined that many foreign manufacturers and shippers of medical gloves have failed to consistently provide medical gloves of adequate quality for distribution in the U. S. surgeon's and examination gloves are widely used by health care professionals and others as a barrier to blood-borne diseases and pathogens. Defective medical gloves present a potential hazard to health for users as well as patients. Therefore, continuous monitoring of these medical gloves is needed.” 

Click here for actual FDA  Import Alert 80-04.

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