Surgical Masks for LTC Facilities: Canadian Regulatory Expectations

September 1, 2026

Monday morning, and the director of care at a 120-bed home in southwestern Ontario is staring at a pallet of masks her purchasing manager just signed for. The price was right, the boxes say "surgical mask," and nobody can find an ASTM rating anywhere on the packaging. That pallet is about to become a compliance problem.

CliniEco ASTM Level 1 procedural face masks, 3-ply, 50 pack

What Health Canada Expects From a Procedure Mask

In Canada, surgical and procedure masks are regulated as Class I medical devices under the Food and Drugs Act. That sounds bureaucratic until an inspector asks to see your product licence numbers, at which point it becomes very practical. Every box you put into circulation should carry a Health Canada medical device licence number or a clear exemption. If a supplier cannot point to one, walk away.

The performance side is handled by ASTM F2100, the standard that grades masks on bacterial filtration efficiency, particulate filtration, fluid resistance and pressure differential. A mask that meets ASTM F2100 has been tested against a published benchmark. A mask without a rating is a guess, and a care home is the wrong place to run that experiment.

ASTM F2100 Levels in Plain Language

Three levels, and the differences matter more than most people think:

Level 1 — low barrier. Good for general care, medication passes and non-aerosol procedures. Least fluid resistance of the three.
Level 2 — moderate barrier. The workhorse for wound care, blood draws and most LTC procedures.
Level 3 — high barrier. For heavier fluid exposure: suctioning, irrigation, procedures where splash is likely.

A Level 1 mask is not "worse" — it is lighter and more breathable, which matters when a PSW wears one for eight hours. The trick is matching the level to the task. For routine care, CliniEco Level 1 procedural masks holds up well; when you need more barrier, ASTM Level 3 face masks and the made-in-Canada Aurelia Level 2 mask made in Canada carry the heavier work.

Matching Mask Level to the Care Setting

Here is the rough map we use when helping homes set par levels:

Routine care and the medication cart: Level 1 or 2
Wound care, catheter care, blood glucose checks: Level 2
Respiratory precautions, droplet contact: Level 2 or 3, per your provincial IPAC guidance
Aerosol-generating procedures: respirator territory — the mask conversation ends and the N95 conversation begins

For a deeper breakdown of how to map ASTM levels to rooms and tasks, our guide on matching face mask levels to your facility walks through the whole matrix.

CSA Z317.10 and the Laundry Question

One angle that surprises new LTC buyers: reusable cloth masks pull CSA Z317.10 into the picture. That standard governs handling of health care textiles, and it imposes laundering, inspection and tracking duties that most homes are not set up to honour. Single-use ASTM-rated masks sidestep that entire category of risk — no reprocessing, no tracking, no questions about whether the washer reached the right temperature.

That is one reason we steer homes toward single-use lines like Aurelia Level 3 masks rather than cloth, and pair them with Level 2 isolation gowns when a procedure calls for more coverage.

Aurelia Level 2 face mask, ASTM F2100 rated, made in Canada

What to Check Before You Sign the PO

Before you commit to a mask order, run this list:

Health Canada licence number printed on the box
ASTM F2100 level stated on the label
Box count and case count that match your weekly burn rate
Ear loop tension — test a sample with staff who wear masks all day
A backup SKU so you are not hostage to one supplier

And if you are rebuilding your stock after a shortage, our LTC infection control supply checklist covers what homes keep on the shelf each week.

Frequently Asked Questions

Q: Are surgical masks regulated in Canada?

A: Yes. Procedure and surgical masks are Class I medical devices under the Food and Drugs Act, administered by Health Canada. Boxes should carry a device licence number, and buyers should verify it before a bulk order lands.

Q: What is the difference between ASTM Level 1 and Level 3 masks?

A: ASTM F2100 grades masks on bacterial filtration, particulate filtration, fluid resistance and breathability. Level 1 offers the lightest barrier and feel for routine care; Level 3 offers the highest fluid resistance of the three, which matters wherever splash is likely.

Q: Do LTC staff need N95 respirators instead of procedure masks?

A: For routine care, a properly fitted procedure mask is the standard. Provincial IPAC guidance requires respirators for aerosol-generating procedures, which is a separate program from your daily mask supply.

Q: Can procedure masks be reused?

A: No. They are single-use devices. Reuse invalidates the ASTM F2100 performance claims and contradicts manufacturer labelling, and reprocessing cloth alternatives pulls in CSA Z317.10 laundering obligations most homes are not set up to meet.