Attn: DQA Regulated Providers
FDA Investigating Certain Imported Medical Gloves
The Department of Health Services (DHS) is making information available from the U.S. Food and Drug Administration (FDA) regarding the use of imported medical gloves. The FDA recommends that health care facilities and providers do not purchase, or use, imported medical gloves from companies included on Import Alert 80-04 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.
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 FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.
FDA Website
For additional information from the FDA regarding this issue, please see: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-gloves-covid-19
Questions If you have questions related to this information please contact CDRH-COVID19-PPE@fda.hhs.gov
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