Counterfeit Nitrile Gloves

The TGA has become aware of issues related to personal protective equipment - nitrile gloves, which are used in both medical and non-medical settings. Certain medical nitrile gloves imported from Thailand have been identified as counterfeit, posing possible safety and quality concerns according to a media report and signal received from the US Food and Drug Administration (FDA). The gloves were found to be of poor quality, contaminated with blood and dirt, and recoloured to give a new appearance.

Medical gloves are used by both healthcare professionals and patients as the first line of defence against illnesses and infections. The supply and use of counterfeit and substandard gloves that have not been manufactured in accordance with safety, performance and quality can present an undue risk to the health of users.

To date, the TGA has not received any reports of adverse events related to these gloves. However, considering the signal received internationally, the TGA has requested the sponsors of these kind of devices to provide information, including any adverse events and complaints, that may relate to these counterfeit and sub-quality products. This will allow the TGA to identify any safety issues and take further action, if necessary.

Reporting problems

Consumers and health professionals are strongly encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

If you have information or suspect non-compliance in relation to therapeutic goods more broadly, you can report illegal or questionable practices online to the TGA.