FAQs
What’s the difference between Medical and Non-Medical Face Masks?
Face masks intended for use by the general public which are non-sterile for non-medical purposes are not medical devices. Masks that are not medical devices are not regulated by the TGA. Examples of such masks include those intended to be used in domestic personal use, construction, security services and other industrial applications. Fluid droplets generated by coughing, sneezing or some medical procedures are widely acknowledged to be a source of pathogen transmission, including the COVID-19 virus. To effectively prevent disease transmission through fluid droplets, facemasks must include a fluid-resistant barrier. Fluid resistance will aid in preventing large droplets and splashes from reaching the mouth or nose, potentially transmitting the virus or other infectious agents.
There has been a significant increase in the domestic manufacture of reusable cloth masks and single-use face masks intended to be used by the general public when social distancing is not possible. These types of face masks are not intended for use in a clinical setting or explicitly to prevent the transmission of disease between persons and therefore are not subject to the same regulations as surgical masks or some respirators.
This type of reusable cloth mask or single-use mask can be manufactured and supplied without requiring to be, and should not be, included on the Australian Register of Therapeutic Goods (ARTG).
However, these masks must not be advertised or labelled in a way that indicates the mask prevents the spread of disease between people, or for the use in healthcare (including aged care) settings. Instead, manufacturers could clearly indicate the mask is designed to be used by the public when social distancing is difficult or for general activity.
These masks may still be appropriate for use in non-medical/healthcare settings to assist in reducing airborne disease transmission, along with social distancing measures.
This information was sourced from the TGA website and if you require further details please refer to this link:
TGA Government Website
What are the 3 Levels of ASTM Barrier Protection?
The following ATSM Barrier levels apply to the amount of protection from fluids/sprays/aerosols that a face mask is able to provide. This applies to both Medical and Non-Medical classed face masks. This is usually referenced on the product packaging as Level 1, Level 2 or Level 3.
Level One: Low Protection
Intended for general use with low-risk, nonsurgical procedures and exams that do not involve aerosols, sprays and/or fluids.
Level Two: Average Protection
Intended for general use with possible exposure to low-to-moderate levels of aerosols, sprays and fluids
Level Three: Higher Protection
Intended for any situation that has the potential for exposure to heavy levels of aerosols, sprays and fluids.