Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
KN95 mask (Aidacare Pty Ltd)
Label name
KN95 mask
Sponsor
ARTG
333179
Manufacturer
Aidacare Pty Ltd
Batch number
20200311
Face mask type
Respirator
Visual inspection
Non-compliant - the TGA’s examination of the goods, label and packaging identified non-compliance with applicable requirements.
Fluid resistance
N/A
Particle filtration
Non-compliant - the Sponsor requested review of the TGA’s non-compliant result with evidence of compliance. Testing from a third-party laboratory upheld the TGA’s finding of non-compliance. Consequently, the test outcome remains as ‘non-compliant’.
Sterility
N/A