Due to the COVID-19 pandemic, the demand for PPE has significantly increased. In response to the greater demand, the TGA has issued guidance on the regulation of face masks, gloves and gowns. The regulation is dependent on the product type and its therapeutic purpose. What is PPE? PPE refers to clothing and equipment (face masks, gloves and gowns) used to protect an individual against one or more health and safety hazards. When is PPE considered a medical device? The regulation defines PPE as articles that are non-sterile personal protective equipment or safety......

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