Made in BC Canada to Health Canada Standards for Facepiece Filtering Respirators
The 95PFE-L3 Health Care + Surgical Particulate Respirator is a single-use medical device designed to help provide respiratory protection for the wearer when used as directed in health care and surgical environments. This respirator has a filter efficiency level of at least 95% PFE against particulate aerosols free of oil (NaCl Challenge). It is fluid resistant to ASTM Level 3 (160 mmHg) and meets ≥ 98% bacterial filtration efficiency (BFE) and particle filtration efficiency (PFE) ≥ 98% (Latex Challenge). It can fit a wide range of face sizes. This product contains no components made from natural rubber latex.
Includes 10 Reusable Adjustment Clips to achieve better seal or reduce pressure on ears
- Health Canada Authorization #:Â 324962; Device ID 1028385
Read more about Health Canada safety and performance specifications here - Meets new Facepiece Filtering Respirators (FFR) performance criteria from Health Canada which is the Canadian standard equivalent to NIOSH N95 Standard (42 CFR 84)
Features
- Comfortable fit with adjustable nose clip
- Provides medical worker protection
- Protects against PM 2.5, dust, pollen
- Includes adjustment clips
- ASTM F2100 Level 3: BFE and PFE ≥ 98%; Synthetic Blood Resistance ≥ 160mmHg
- Meets Canada 95PFE Guidelines: PFE>95% (NaCl Challenge)
- Exceeds NIOSH N95 PFE Levels
- Advanced electrostatically charged microfibers
- Graphene free
- Made in CanadaÂ
Approvals/Standards
- ASTM F2100 Level 3 Qualified
- Compliant with Health Canada Guidance for 95PFE-L3 Facepiece Filtering Respirators (FFRs)
- GB 2626-2019 CertifiedÂ
Intended Use
As a health care + surgical particulate respirator, this product is intended to help reduce wearer exposure to certain airborne particles, including small particle aerosols and large droplets (only non-oil aerosols). As a medical + surgical mask, this product is designed to be fluid resistant to provide the wearer protection against large droplets, splashes, or sprays of bodily or other hazardous fluids. It is also designed to protect the patients and other individuals in the vicinity from the wearer’s respiratory emissions.
Specifications
- Protections Level: ASTM Level 3
- Delta Differential Pressure:Â <6.0mm H2O/cm2
- Particle Filtration Efficiency: PFE ≥98%
- Fluid Resistance: 160 mmHg
- Material: Meltblown, Non-woven fabrics
- Nose Wire Material: Plastic Polymer with metal iron wire
- Ear Loops Material: Elastane, polyester
- Size: One Size Fits Most
- Sterility: Non-Sterile
- Colour: White
- Style: Folding
- Fastening Style: Ear Loops
- Manufacturer: Layfield Medical Products
- Country of Origin: Canada
- Packaging: box of 30 masks (12 box/case)
- Product Code: MLL-1970E, 778299060103
Period of Use
- Shelf Life: 2+ years from the manufacturing date
- Subject to the Storage Conditions specified below, the mask may be used until the expiry date printed on the packaging​
- One-time use only. When the mask is contaminated or damaged replace it with a new one.
Disposal
- Dispose of respirator according to your facility or institution or employer policy, and local regulations​
Storage and Transportation
- Product should be stored in clean, dry conditions within the temperature range: -10°C to +40°C with a relative humidity of <85%​
- When storing or transporting this product, use original packaging provided​
M6060B
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