Medicom Safe + Mask Premier Plus Procedure Earloop Face Mask (A R Medicom Australia Pty Ltd)
Label name
Medicom Safe + Mask Premier Plus Procedure Earloop Face Mask
Sponsor
Manufacturer
A.R. Medicom Inc (Shanghai) Co Ltd
Batch number
5111010835
Face mask type
Surgical Mask
Visual inspection
Label Deficiencies - an examination of the label and/or packaging identified non-compliance with applicable requirements.
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