IPKIS P2 Surgical Respirator (Evolve Group Pty Ltd)
Label name
IPKIS P2 Surgical Respirator
Sponsor
ARTG
344488
Manufacturer
Evolve Group Pty Ltd
Batch number
N/A
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
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