Product Description
- Product name : Medicom SafeMask® Architect Pro
- Product type : Single use, non-sterile, three layer construction
- Strap: Latex-free synthetic rubber
- Nose bridge: Plastic-coated iron
- Color: White
- Size: Small
- Quantity per inner box: 50
- Country of origin: Canada
FEATURES AND BENEFITS
- Reliable respiratory protection that filters out 95% of oil-free particulate aerosols.
- High quality materials and duckbill shape.
- Lightweight and breathable construction.
- Unique two-part comfort band.
- Adjustable nose bridge.
RECOMMENDED USE
- Effective against oil-free particulate aerosols; restrictions on duration of use may apply.
CERTIFICATION & STANDARDS
- ISO 13485 certified manufacturer.
- Class 1 medical device.
- Manufacturer registered with Health Canada.
The SafeMask Architect Pro N95 surgical respirator has received NIOSH (National Institute for Occupational Safety and Health) approval from the Centers for Disease Control and Prevention (approval number TC-84A-9375).
NIOSH certification means that the respirator complies with the requirements set forth in Part 84, Title 42, Code of Federal Regulations of the United States.
TESTS, METHODS AND RESULTS
- Biocompatibility: cytotoxicity, skin sensitization and skin irritation - ISO 10993-5, ISO 10993-10: complies with the standard
- Particulate filter efficiency (PFE) - 42 CFR 84 : ≥ 95 %
- Airflow resistance - 42 CFR 84: Inhalation < 35 mm H20. Exhalation < 25 mm H20
- Fluid resistance (resistance to penetration by synthetic blood) - ASTM F1862: (Level 2) 120 mm Hg
- Flammability - 16 CFR 1610: Class 1 - compliant
- Fit - CAN/CSA Z94.4: A combination of all sizes fits over 90% of users
