ASTM Mask Levels 1-3: PFE & Fluid Resistance for Clinics

If there's one piece of PPE that creates more confusion than any other in my line of work, it's the face mask. Not because it's complicated—but because the terminology has been muddied over the past few years.

I've had clinic managers ask me: "What's the difference between a procedural mask and a surgical mask?" "Do I need ASTM Level 3 for routine exams?" "Are KN95s the same as N95s?"

These are fair questions, and the answers matter—both for staff safety and supply budget. Here's what I've learned from sourcing masks for Canadian healthcare facilities.

The ASTM Classification System

ASTM International (formerly the American Society for Testing and Materials) created standard F2100 to classify medical face masks by their performance across four key metrics. Nearly every medical mask sold in Canada falls under this system.

The numbers that matter most for purchasing decisions are BFE (how well the mask filters bacteria) and fluid resistance (how well it holds up against splashes and sprays).

ASTM Level 1 is the baseline for medical face masks. It provides ≥95% bacterial filtration and 80 mmHg fluid resistance—sufficient for routine exams, patient interaction, and general clinical use. It's also the most breathable. CliniEco Medical carries ASTM Level 1 procedural masks for routine clinical use.

ASTM Level 2 steps up filtration to ≥98% and fluid resistance to 120 mmHg. This is appropriate for moderate-risk settings—think suturing, blood draws, or dental procedures where aerosol generation is possible.

ASTM Level 3 offers the highest fluid resistance (160 mmHg) among non-surgical masks. Facilities that need higher fluid protection can order ASTM Level 3 face masks in 50-pack boxes. It's designed for high-risk procedures where fluid splash is expected, such as surgery or trauma care. Note: Level 3 is still not a respirator—it's a mask.

Procedural Masks vs. Surgical Masks: The Real Difference

A lot of confusion comes from these two terms. Here's the short version:

Procedural masks are ASTM-rated face masks intended for use in medical settings. They meet ASTM F2100 requirements and are cleared by Health Canada as Class I medical devices. Most procedural masks on the market are Level 1 or Level 2.

Surgical masks are also ASTM-rated and meet the same F2100 standard. The difference is that surgical masks have undergone additional fluid-resistance testing to qualify for use in the sterile field during surgery. They are typically Level 2 or Level 3.

In practice, if your staff are doing routine examinations and patient-facing work, ASTM Level 1 procedural masks are clinically appropriate and more comfortable to wear all day. If you're running a dental clinic, surgical suite, or emergency department, you need Level 2 or Level 3.

KN95, N95, and Respirators: A Quick Note

KN95s and N95s are not face masks under ASTM F2100—they are respirators certified under different standards (NIOSH N95 or GB2626 KN95). They form a tight seal around the face and filter ≥95% of airborne particles.

For most clinical settings, respirators are not needed for routine patient care. They are reserved for:

• Aerosol-generating medical procedures (intubation, suction, nebulized treatments)
• High-risk respiratory infection cases
• Procedures requiring a fitted seal

If you're buying masks for everyday clinic use, ASTM Level 1 or 2 masks are the right choice. Stocking respirators separately for the situations that require them is more cost-effective than buying them as your everyday mask.

How Many Masks Does Your Clinic Need?

Usage varies depending on the type of facility and patient volume. Here's a rough guide I use when helping clinics set up their PPE budgets:

At $12.99 per box of 50 (our CliniEco Level 1 procedural masks cost $0.26 per mask), a clinic with 5 providers going through roughly 300 masks per month would spend around $78 per month on mask supplies. Compare that to brand-name distributors charging $20-$35 per box for the same ASTM Level 1 rating, and the annual difference adds up.

Quick Checklist for Your Next Mask Order

• [ ] Confirm the ASTM level needed for your clinical setting (Level 1 for routine, Level 2-3 for higher risk)
• [ ] Verify the supplier provides ASTM F2100 certification documentation
• [ ] If buying surgical masks, confirm the product has a Health Canada MDL
• [ ] Check the fluid resistance rating (80, 120, or 160 mmHg)
• [ ] Factor in per-mask cost, not per-box cost
• [ ] Ensure the masks fit your staff population (ear loops vs. headbands, sizing)

A Final Thought

When I look at mask purchasing across the clinics we supply, the most common mistake isn't buying the wrong mask—it's buying more mask than needed and paying for it. Level 1 procedural masks are perfectly appropriate for the vast majority of clinical interactions, and they're significantly more comfortable for staff who wear them all day.

The higher levels exist for a reason—but if your clinic isn't doing surgical procedures or managing high-risk respiratory cases, Level 1 is where your budget goes furthest without compromising care.

CliniEco Medical is an Ontario-owned supplier of ASTM-rated procedural face masks, exam gloves, and medical consumables. All our products meet Health Canada requirements and are stocked in our Toronto warehouse.

Related Reading

Explore more guides in this category:

• CliniEco 3-ply face masks in bulk clinic packs
• PLA Dental Bibs: Compostable Patient Bibs for Modern Dental Practice
• PLA Shoe Covers: Biodegradable Footwear Protection for OR and Clinic
• PLA Bouffant Caps: Compostable Hair Covers for Cleanroom and Clinic

Frequently Asked Questions

What is the difference between ASTM Level 1, 2, and 3 masks?

Under ASTM F2100, the levels differ in filtration and fluid resistance. Level 1 has BFE and PFE of at least 95% and 80 mmHg fluid resistance; Level 2 has at least 98% filtration and 120 mmHg; Level 3 has at least 98% filtration and 160 mmHg. Higher levels are for higher splatter risk, not necessarily better protection in routine use.

Which ASTM level does my clinic actually need?

Level 1 is suitable for general care and low-splatter settings like reception or routine exams. Level 2 is for procedures with moderate splash potential. Level 3 offers the highest fluid resistance and is recommended for surgery and procedures where blood or fluid splash is likely. Match the level to the task rather than always buying Level 3.

Is an ASTM Level 3 mask the same as an N95?

No. ASTM F2100 rates medical face masks for bacterial filtration, particulate filtration, and fluid resistance. N95 is a respirator standard from NIOSH that measures filtration of airborne particles and requires a fit test. They are different products with different certifications — a Level 3 mask is not a respirator.

What do BFE and PFE mean on mask packaging?

BFE is bacterial filtration efficiency — how well the mask filters bacteria-sized particles (3 microns). PFE is particulate filtration efficiency — filtration of smaller particles (0.1 micron). Under ASTM F2100, Level 1 masks must achieve at least 95% BFE and PFE; Levels 2 and 3 must achieve at least 98%.

For facility and bulk orders of disposable medical supplies in Canada, contact the CliniEco Medical team — a licensed medical device establishment (MDEL #35334).

Related reading: explore our infection control resources for clinics.

decode HAI, SSI, CJD and MDRO acronyms in our infection control pillar article.