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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
Non-compliant - the TGA’s examination of the goods, label and packaging identified non-compliance with applicable requirements.
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