Health Canada Medical Device Establishment Licence
MDEL: Health Canada Medical Device Establishment Licence, Company ID 163729.
FOR US ALL
Medical Grade Surgical Masks
The SCM-34N is certified to ASTM F2100-19e1 Level 3. In Richmond, BC, we have the capability to produce sterile masks in-house through ethylene oxide sterilisation.
ASTM F2100-19e1LEVEL 3
SCM-34N at a glance
160 mmHgFluid resistanceASTM F1862 Level 3 · KIN 975020-21-PPE-00134
99.94%Particulate filtrationASTM F2299 · KIN 975020-21-PPE-00134
163729Health Canada MDELMedical Device Establishment Licence Company ID
Our published proof
We publish the documents buyers need to check our licence, certification and test results.
Together, these documents let you check our Health Canada establishment licence, ASTM F2100-19e1 Level 3 certification and test results in report KIN 975020-21-PPE-00134.
Download PDF ↗
ASTM Level 3 Certification
Certification for Medical Grade Surgical Masks to ASTM F2100-19e1 Level 3.
Full test results report KIN 975020-21-PPE-00134
Summary report of the mask’s test results.
The SCM-34N
Medical Grade Surgical Masks, specified by construction and tested to the standard procurement teams name.
- Ply / fold
- 3-ply / 4-fold
- Fabrics
- High-density, high-filtration spunbond and meltblown non-woven fabrics
- Ear loops
- 4.5 mm extra-wide; sized for all adult face types
- Standard
- ASTM F2100-19e1 Level 3
Sterile in-house
Our in-house sterilisation capability is part of how we make surgical masks here in Richmond.
We are the only Canadian PPE manufacturer that has the capability to produce sterile masks in-house through a specialised ethylene oxide sterilisation process.
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From our Richmond facility, we make Medical Grade Surgical Masks and stay connected to the community around us.
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