Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves

Why FDA issued it

NOTE: Revision of this Import Alert dated 10/20/2010 updates the Guidance section to reflect current terminology and also updates the contact information. Changes are bracketed by asterisks (***). CDRH 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.

Quoted from the “Reason for Alert” section of the FDA page for 80-04, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.