COVID-19 personal protective equipment

Personal protective equipment (PPE) includes face masks, respirators, gowns and gloves.

In Australia, the TGA regulates PPE if a manufacturer makes any of the following claims the:

• PPE is to be used for preventing the transmission of disease between people
• PPE is suitable for therapeutic use, such as surgical, clinical, or medical use, or use in other health services.

If the manufacturer's labelling, advertising, or documentation contain the claims above, the PPE is considered to be a medical device and is required to be included in the Australian Register of Therapeutic Goods (ARTG).