Authorized by Health Canada for Use Related to COVID-19
Made in Canada (Richmond, BC)
Health Canada 95PFE compliant for Filtering Facepiece Respirator (FFR)
KN95 performance per GB 2626-2019
This highly breathable flat fold earloop disposable respirator mask has >95% PFE, ASTM Level 3 surgical mask rating, and meets the KN95 performance requirement per GB 2626-2019 (the Chinese standard). Health Canada has authorized it as a 95PFE Surgical Respirator.
Graphene Free
Made in Canada by Layfield Medical Products, the 95PFE-L3 particulate respirator is a vertical flat-fold Surgical Respirator face mask with ear loops. It is designed for respiratory protection for the wearer in healthcare or everyday applications when used as directed. This respirator has a filter efficiency level of at least 95% PFE against particulate aerosols (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 Reusable Adjustment Clips to achieve better seal or reduce pressure on ears
Usage Tip: try flattening the nose wire to mostly remove the peak, then bend it aggressively in an arc shape to better follow your nose without peaking. This may improve comfort and reduce leakage.
Approvals/Standards
- Health Canada authorized respirator for COVID-19 searchable here with authorization 324962, device identifier MLL-1970E.
- Compliant with Health Canada Guidance for 95PFE Facepiece Filtering Respirators (FFRs) (respirator test report)
- ASTM F2100 Level 3 Qualified (ASTM test report)
- Meets GB 2626-2019 KN95 Performance (test report)
- Note: this mask is not NIOSH N95. The particulate filtration of this mask has been tested by ICS Inc. Laboratories using the NIOSH standard procedure TEB-APR-STP-0059, and the particulate filtration efficiency of the test samples was measured >95% (Test Report)
- Note: earloops do not meet the headband requirement of NIOSH N95
Features
- Comfortable fit with adjustable nose clip to prevent leaks and foggy glasses
- Excellent breathability
- Includes adjustment clips to reduce ear strain or achieve tighter fit
- ASTM F2100 Level 3: BFE and PFE ≥ 98%; Synthetic Blood Resistance ≥ 160mmHg
- Meets Canada 95PFE Guidelines: PFE>95% (NaCl Challenge)
- Advanced electrostatically charged microfibers
- Fits many average-sized adults and some teens
- SKU MLL-1970E
- Manufactured in Richmond, BC, Canada by Layfield Canada Ltd., a Health Canada MDEL license holder
- Made in Canada
Specifications
- Protections Level: ASTM Level 3
- Delta Differential Pressure: <6.0mm H2O/cm2
- Particle Filtration Efficiency: PFE ≥98% (ASTM F2299 method, 0.1um polystyrene latex spheres)
- Fluid Resistance: 160 mmHg
- Body Material: Meltblown and non-woven fabrics. 100% polypropylene.
- 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 A: box of 10 masks (280 masks/case)
- Packaging B: box of 30 masks (360 masks/case)
- Product Code: MLL-1970E
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
- Dispose after 8 hours of accumulated use (e.g. eight 1-hour trips to the grocery store, or one 8-hour work day). If the mask is contaminated or damaged replace it with a new one.
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
Shop Local. Shop Canadian.
Note: Canada Strong Masks is a Health Canada licensed distributor with MDEL #18557. Due to safety requirements, we are unable to accept returns on masks or respirators even if unopened.