FDA Investigating Certain Imported Medical Gloves

Earlier this month, the Association of periOperative Registered Nurses (AORN) advised that the FDA is investigating certain imported medical gloves. The FDA recommends that health care facilities and providers not purchase, or use imported medical gloves from the companies included on Import Alert 80-04 Surveillance and Detention Without Physical Examination of Surgeon’s and Patient Examination Gloves.   Those companies appearing on the red-list, or do not purchase/use list appear at the end of the alert.

To help expand the availability of medical gloves and other Personal Protective Equipment, during the COVID-19 public health emergency, the FDA provided regulatory flexibility under certain circumstances intended to prevent devices from presenting an undue risk, as described in the enforcement policy for gloves during the COVID-19 public health emergency. While the reference document is dated March 2020, regular updates about medical gloves, and other PPE, including the answers to frequently asked questions can be found on this page.

FDA-cleared medical gloves, can be identified simply by searching the 510(k) Premarket Notification database using the product codes for medical gloves.

Report a Problem with Medical Gloves

If you have purchased any medical gloves that are visibly soiled, are a different color, appear to have been used, or otherwise seem to be fraudulent, please report it to the FDA by email to [email protected].

Want to learn more about the proper use of medical gloves and PPE? See our C_APPS tools and resource package, Personal Protective Equipment (PPE).

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