The Center for Devices and Radiological Health (CDRH), a part of of the Food and Drug Administration, issued an import alert January 4 following determination that the many foreign glove manufacturers have “failed to consistently provide medical gloves of adequate quality”.  According to the alert, more than 200 glove manufacturers are currently in detention; of those, 16 are in Level 2 and 12 are in Level 3 detention.

When inspected medical gloves fail to meet Good Manufacturing Practices (GMP) upon FDA inspection, the manufacturer is placed in one of three levels of detention whereby any shipment may be detained by the FDA without physical examination.  Repeat offenders face escalating levels of detention, with each level requiring additional evidence of compliance in order to be removed from the list.  In Levels 1 and 2, manufacturers must provide consecutive independent lab test results confirming that their medical gloves are not adulterated for removal consideration.  Removal from Level 3 detention also requires independent audits or FDA inspection.

We applaud the FDA for its continued efforts to ensure the safety of those whom rely on medical gloves for protection.