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MSK-003, Cocoon Duckbill Respirator Mask, Regular Size (Care Essentials Pty Ltd)
Label name
MSK-003, Cocoon Duckbill Respirator Mask, Regular Size
Sponsor
Manufacturer
Care Essentials Pty Ltd
Batch number
DB-041021
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