Medicom Safe Mask Procedure Earloop Face Mask I (A R Medicom Australia Pty Ltd)
Label name
Medicom Safe Mask Procedure Earloop Face Mask I
Sponsor
Manufacturer
A.R. Medicom Inc (Shanghai) Co Ltd
Batch number
5111009166
Face mask type
Surgical Mask
Visual inspection
Non-compliant
Fluid resistance
Non-compliant (disputed) - The sponsor disputed the TGA non-compliant result with evidence of compliance. However, additional 3rd party testing could not proceed to resolve disparity as insufficient masks available from same batch, or batch had expired.
Particle filtration
N/A
Sterility
N/A