FDA Investigating Certain Imported Medical Gloves - Recommends Suspending Use

November 3, 2021

The U.S. Food and Drug Administration recommends that health care facilities and providers not buy or use imported medical gloves from certain companies. There are concerns with glove quality. Access Import Alert 80-04 Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves for a list of companies.

Use the 510(k) Premarket Notification database with the code for medical gloves to identify FDA-cleared gloves.

Providers should report any medical glove purchases to the FDA by email that are a different color, appear used, soiled, or otherwise seem to be fraudulent.