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 also has ASTM Level 3 surgical mask rating and KN95 rating 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
Tip: flatten the nose wire to mostly remove the peak, then bend it aggressively as a bigger arc to follow your nose.
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)
- GB 2626-2019 Certified KN95 (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 most adults and teenagers 13+
- 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%
- 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 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
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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.