Based on these tests, masks are rated as Level 1, Level 2, or Level 3. There is no "Level 4" in ASTM F2100; anything marketed as such is outside this standard.
ASTM Mask Level Comparison
| Property | Level 1 (Low Barrier) | Level 2 (Moderate Barrier) | Level 3 (High Barrier) |
|---|---|---|---|
| Fluid Resistance | 80 mmHg | 120 mmHg | 160 mmHg |
| BFE (Bacterial Filtration) | ≥95% | ≥98% | ≥98% |
| PFE (Particulate Filtration) | ≥95% at 0.1 µm | ≥98% at 0.1 µm | ≥98% at 0.1 µm |
| Delta P (Breathability) | < 4.0 | < 5.0 | < 5.0 |
| Flame Spread | Class 1 (slow burn) | Class 1 | Class 1 |
When to Use Each Level in Canadian Clinics
ASTM Level 1 (Low Barrier)
Level 1 masks offer the lowest fluid resistance (80 mmHg) but the best breathability. They are ideal for low-risk, non-aerosolizing procedures where fluid splash is minimal. Typical uses in Canadian clinics include:
- General patient consultations and examinations
- Administrative and reception areas during flu season
- Dental hygiene cleanings
- Community health settings with low infection risk
Level 1 masks are the most comfortable for all-day wear, making them a popular choice for front-office staff in Canadian clinics.
ASTM Level 2 (Moderate Barrier)
Level 2 masks provide moderate fluid resistance (120 mmHg) with excellent filtration (≥98% BFE/PFE). They are the standard choice for most clinical procedures. Typical uses include:
- Suturing and minor surgical procedures
- Blood draws and IV insertion
- Dental procedures with moderate splash risk
- General nursing care in hospitals and clinics
Level 2 is the most commonly specified ASTM level for Canadian clinic procurement, offering the best balance of protection and breathability for daily use.
ASTM Level 3 (High Barrier)
Level 3 masks offer the highest fluid resistance (160 mmHg) and are required when there is a risk of high-velocity fluid splash or aerosol generation. Typical uses include:
- Oral surgery and periodontal procedures
- Emergency department triage of respiratory patients
- Procedures involving power tools (drills, ultrasonic scalers)
- Any situation where significant blood or fluid splash is expected
Level 3 masks are thicker and slightly less breathable than Level 1 or 2, but provide the highest level of barrier protection under the ASTM standard.
Health Canada Requirements
Health Canada regulates medical masks as Class I medical devices. To sell ASTM level masks in Canada, manufacturers and importers must hold a valid Medical Device Establishment Licence (MDEL). The masks must also be tested by an accredited laboratory to ASTM F2100 standards.
Key compliance points for Canadian clinic procurement teams:
- Verify the supplier holds a valid Health Canada MDEL
- Request ASTM F2100 test reports from an accredited lab (e.g., Nelson Labs, NAMSA)
- Ensure the mask packaging lists the ASTM level and certification
- Confirm the masks are not expired — surgical masks have a limited shelf life
Which Level Should Your Canadian Clinic Stock?
For most Canadian clinics, a two-tier strategy works best:
- Level 1 for admin staff, reception, and low-risk consultations
- Level 2 or 3 for clinical staff performing procedures (choose Level 3 for high-splash dental or surgical work)
By understanding the ASTM F2100 standard and matching mask levels to clinical risk, your clinic can ensure compliance, protect staff, and control PPE costs. CliniEco Medical supplies a full range of Health Canada-compliant ASTM level masks across Canada, with bulk pricing for clinics and healthcare facilities.
Need these supplies for your facility? CliniEco Medical serves Canadian clinics, laboratories and long-term care homes. Open a wholesale account for institutional pricing.
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