A-Med Surgical Respirator P2 Level 3 (SM-RA201) (SOFTMED MANUFACTURING PTY LTD)
Label name
A-Med Surgical Respirator P2 Level 3 (SM-RA201)
Sponsor
Manufacturer
SOFTMED MANUFACTURING PTY LTD
Batch number
L2021605
Face mask type
Surgical Respirator
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
Compliant
Sterility
N/A