A medical face mask sold in the United States is classed under ASTM F2100. The same mask sold in Europe is classed under EN 14683. The two standards test similar things with different thresholds and one important difference in what they require. Buyers selling into both markets need a mask that passes both, and a label that says so.
Side by Side
| Test | ASTM F2100 Level 1 | Level 2 | Level 3 | EN 14683 Type I | Type II | Type IIR |
|---|---|---|---|---|---|---|
| Bacterial filtration efficiency | 95% or more | 98% or more | 98% or more | 95% or more | 98% or more | 98% or more |
| Particulate filtration, 0.1 micron | 95% or more | 98% or more | 98% or more | Not required | Not required | Not required |
| Fluid resistance, synthetic blood | 80 mmHg | 120 mmHg | 160 mmHg | Not required | Not required | 16.0 kPa (about 120 mmHg) |
| Breathability, differential pressure | Under 5.0 mmH2O/cm2 | Under 6.0 | Under 6.0 | Under 40 Pa/cm2 | Under 40 Pa/cm2 | Under 60 Pa/cm2 |
| Flammability | Class 1 | Class 1 | Class 1 | Not required | Not required | Not required |
| Microbial cleanliness | Not required | Not required | Not required | 30 cfu/g or less | 30 cfu/g or less | 30 cfu/g or less |
What the Differences Mean
ASTM requires particulate filtration and flammability; EN does not. EN requires microbial cleanliness (bioburden); ASTM does not. Fluid resistance is the line that matters clinically: only ASTM Levels 1 to 3 and EN Type IIR are splash resistant. A Type II mask is a high filtration mask with no splash claim, and it should not be sold as a surgical mask.
Which to Specify
- General clinical use, no splash risk: ASTM Level 1 or EN Type II.
- Procedures with splash risk: ASTM Level 2 or 3, or EN Type IIR.
- Selling into both markets: a mask tested to ASTM Level 2 and EN Type IIR, with both reports on the Trust ID.
A Note on Origin for US Buyers
Face masks from China carry a 50% Section 301 surcharge for US delivery since January 2026. For US programs we quote a second origin alongside China. See the tariff page.
Where to Go from Here
Every gown and drape on our protective apparel page is listed with its level, tests and construction. The tariff page carries the current duty picture for US buyers, and the quotation request takes a spec, a SKU or a competitor's item.