The FDA recommends that healthcare 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 healthcare 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, please report it to the FDA by email (see link below).
The FDA continues to take a number of steps to find and stop those selling unsafe and unapproved products by investigating, examining and reviewing medical products, both at ports of entry and within domestic commerce, to help ensure the safety of our national supply chain.
To help expand the availability of medical gloves during the COVID-19 public health emergency, the agency is providing regulatory flexibility under certain circumstances intended to prevent the devices from presenting an undue risk, as described in the enforcement policy for gloves during the COVID-19 public health emergency. The FDA is also providing regular updates about 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].
