FDA Investigating Certain 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 [email protected].

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