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.
Medical Protective Mask ' Esound Med (GB 19083-2010, PFE=95% [grade unspecified]) (ASPEN MEDICAL PTY LIMITED)
Label name
Medical Protective Mask ' Esound Med (GB 19083-2010, PFE=95% [grade unspecified])
Sponsor
ARTG
335542
Manufacturer
ESound Medical Device Co Ltd
Batch number
200411615
Face mask type
Surgical Respirator
Visual inspection
Non-compliant - the TGA’s examination of the goods, label and packaging identified non-compliance with applicable requirements.
Fluid resistance
Non-compliant
Particle filtration
Compliant
Sterility
Non-compliant