Isolation gown levels look portable across the border because the AAMI PB70 scale is used in both Canada and the United States. The levels describe barrier performance rather than a national rule, so a Level 2 gown is a Level 2 gown in either country. What a buyer has to check separately, once again, is the documentation that places the product on each market.
Which isolation gown levels apply in Canada vs the United States?
AAMI PB70 defines four levels of barrier performance for gowns, from Level 1 for minimal fluid exposure through to Level 4 for the highest. The scale is a performance framework, not a national regulation, and Canadian and US buyers both use it to describe what a gown is intended to protect against. A clinic selecting by level is selecting by expected fluid exposure, which is the same decision in both markets.
| Level | Typical use | Same in both markets? |
|---|---|---|
| Level 1 | Minimal fluid exposure, basic care | Yes, performance framework |
| Level 2 | Low fluid exposure, suturing, blood draws | Yes, performance framework |
| Level 3 | Moderate fluid exposure, arterial draws | Yes, performance framework |
| Level 4 | High fluid exposure, longer procedures | Yes, performance framework |
The table is deliberately the same on both sides, because the level is a property of the gown. Where the two markets part company is in the administrative layer: how the product is placed on the market, and what evidence a buyer can request to confirm that placement.
How does fabric choice interact with the level?
Different fabrics reach the same level in different ways. A non-woven gown can be constructed to reach a modest level with a light fabric, while a higher level usually requires a heavier fabric or a coating. SMMS construction, which layers spunbond and meltblown material, is a common way to reach a moderate level with breathability. A buyer choosing by level should also note the fabric, because two gowns at the same level can differ in comfort, cost and how they behave in a long procedure.
What should a buyer verify for a cross-border order?
Confirm the level, the fabric and the market-placement reference for the country of sale. In Canada, that means the establishment licence framework for the importer placing the gown on the market; in the United States, the device pathway the supplier uses. The level tells you what the gown protects against, while the placement reference tells you it is legitimately supplied in that country. A purchase order that captures only the level has captured half the requirement.
How should a clinic choose a level?
Choose by expected fluid exposure and procedure length, not by habit. A basic care setting rarely needs more than Level 1, while procedures with anticipated fluid contact call for a higher level. Over-specifying increases cost and reduces comfort, which can reduce compliance, so the level should match the task rather than the whole facility.
What should be recorded?
Record the gown level, the fabric, the supplier's market reference and the lot number on receipt. If a barrier question is raised, the lot number is what makes a batch traceable. Recording only the level leaves the clinic unable to identify which gowns were used in a specific period, which is the point of keeping the record at all.
How should gowns be stored and donned?
Store gowns in a clean, dry area and keep them in their packaging until use, because a gown exposed to damp loses the properties the level describes. Don the gown after hand hygiene, and doff it by pulling the gown away from the body so the contaminated outer surface does not touch the wearer or their clothing. Where a facility keeps an outbreak cart, pre-pack the gown alongside the other items for that procedure, so the sequence is not improvised under pressure. The level sets what the gown can do; the donning sequence decides whether that capability is realised in practice.
What does fabric weight add to the level?
Fabric weight, often quoted in grams per square metre, gives a clue about how a gown reached its level, but it is not a substitute for the level itself. A heavier fabric generally resists fluid for longer, while a lighter fabric relies on its construction to achieve the same claim. Two gowns at the same level can therefore feel and cost quite differently, and a clinic should choose between them on procedure length and comfort rather than on weight alone. Recording both the level and the fabric in the purchase record keeps that choice visible when the product is next reviewed.
Does level replace other precautions?
No. Gown level addresses barrier performance against fluid, and it sits alongside hand hygiene, glove use and the sequence of donning and doffing. A clinic that selects the right level but doffs incorrectly has not managed the exposure. The level is one control in a sequence, and it should be treated as such rather than as a standalone assurance.
Isolation gowns: the SMMS isolation gown, Level 2, 50 pack, the disposable Level 1 non-woven gowns, and the PLA biodegradable Level 1 gowns. For facility accounts, request the BI 5-pack sample when monitoring is also in scope.
Download the free printable compliance log sheet and run the log sheet generator. Ordering for a clinic, lab or care home? Wholesale and multi-site ordering covers case pricing and account setup, and the B2B wholesale collection lists the lines stocked for institutional buyers. For site-specific guidance, ask a sterilization compliance specialist. Reselling? become a distributor.
Related reading
AAMI PB70 isolation gown levels · Ontario infection-control rules in 2026 · Case cart assembly and sterile storage
Frequently Asked Questions
Are isolation gown levels the same in Canada and the US?
Yes. AAMI PB70 describes barrier performance, and the same four levels are used in both markets, so a Level 2 gown is Level 2 in either country. Only market placement differs.
Which isolation gown level should a clinic choose?
Choose by expected fluid exposure and procedure length. Basic care rarely needs more than Level 1, while procedures with anticipated fluid contact call for a higher level.
Does gown level replace other precautions?
No. Level addresses barrier performance against fluid and sits alongside hand hygiene, glove use and correct donning and doffing. It is one control in a sequence.
CliniEco Medical is a licensed medical device establishment (MDEL #35334).
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