Medicom Pro-Shield Masks with Visor (A R Medicom Australia Pty Ltd)
Label name
Medicom Pro-Shield Masks with Visor
Sponsor
Manufacturer
A.R. Medicom Inc (Shanghai) Co Ltd
Batch number
5111010979
Face mask type
Surgical Mask
Visual inspection
Compliant
Fluid resistance
Compliant - the Sponsor requested review of the TGA’s non-compliant result with evidence of compliance. Testing from a third-party laboratory supported the Sponsor’s evidence of compliance. Consequently, the TGA’s non-compliant result was overturned.
Particle filtration
N/A
Sterility
N/A