Situation Report | November 8, 2021
The U.S. Food and Drug Administration (FDA) recommends that health care facilities and providers do not purchase, or use imported medical gloves from companies included on Import Alert 8880-04: “Surveillance and Detention Without Physical Examination of Surgeon’s and Patient Examination Gloves.”
Companies are listed on an import alert when the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of their products as they appear to be in violation of the FDA’s laws and regulations and thus, create a potential risk to health care professionals, patients and users.
To identify FDA-cleared medical gloves, search the 510(k) Premarket Notification database, using the product codes for 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, the FDA requests that you report it to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.
More information is available on the FDA website.