Examination glove requirements in Canada and the United States converge on performance and diverge on market authorisation and labelling. Both markets work from the same ASTM test methods for pinholes and dimensions, but a glove that is compliant in one country is not automatically compliant in the other. The differences that catch buyers are the Canadian bilingual label requirement, the device class assigned to exam gloves, and whether a premarket submission is required at all.
For a clinic group buying across the border, the practical answer is to buy from a supplier that can show the test report and the label, not just the box. A 4.0 mil powder-free nitrile examination glove is a useful reference product because its specification sheet carries the test methods that both markets recognise.
How are examination gloves classified in Canada and the United States?
In Canada, examination gloves are Class II medical devices. The manufacturer holds a medical device licence for the product, and an importer or distributor holds a Medical Device Establishment Licence. In the United States, examination gloves sit in Class I under 21 CFR 880.6250 and are exempt from premarket notification, but the establishment must still register and list the device, and the product must meet the recognised performance standards. Surgical gloves are a different case in both countries and are Class II in the US.
| Requirement | Canada | United States |
|---|---|---|
| Device class for exam gloves | Class II | Class I |
| Premarket submission | Medical device licence held by the manufacturer | Exempt from premarket notification under 21 CFR 880.6250 |
| Establishment requirement | MDEL for importer or distributor | FDA establishment registration and device listing |
| Performance standard | ASTM D6319 for nitrile exam gloves; ISO 11193-1 also recognised | ASTM D6319 for nitrile; ASTM D3578 for latex |
| Pinhole acceptance | Watertight test at AQL 1.5 per ASTM D6319 | Watertight test at AQL 1.5 per ASTM D6319 |
| Label language | English and French required | English |
Why does the bilingual label matter for Canadian buyers?
Canadian medical device labelling rules require both English and French on the device label and instructions. A pallet of gloves with an English-only box is a compliance problem for the Canadian distributor even when the gloves themselves pass every physical test. Buyers who source from a US listing and re-label in Canada take on that obligation, and re-labelling in a warehouse is a controlled activity, not a sticker exercise.
Check three things on the box: the licence or registration number referenced by the supplier, the bilingual text, and the lot number with an expiry date. If the box carries only a manufacturing date with no expiry, ask for the shelf-life statement in writing.
Do exam gloves have to meet pinhole limits?
Yes, and the limit is set by the ASTM watertight test at an acceptance quality limit of 1.5. That is a statistical limit applied to a lot, not a promise that every glove is free of pinholes. It is also why glove thickness alone does not tell you whether a glove will leak: a 4.0 mil glove that meets the AQL is a better barrier than a thicker glove that does not. Buyers comparing quotes should ask for the lot test report rather than the marketing thickness figure.
Chemotherapy-rated gloves carry an additional claim. A chemo-rated nitrile glove is tested for permeation against a defined panel of cytotoxic drugs, and that test is separate from the pinhole test. If your clinic prepares hazardous drugs, the product needs both.
What changes for a clinic that buys in both markets?
Keep two specification files. The physical specification can be identical if you standardise on ASTM D6319 for nitrile, but the market authorisation evidence is different: a Canadian file needs the licence reference and bilingual artwork, and a US file needs the establishment registration and listing. Do not let a US supplier's "FDA registered" statement stand in for a Canadian licence, and do not assume a Canadian licence covers a US site.
Glove selection also interacts with the rest of the infection control programme. If your team is rebuilding sterilization records at the same time, keep the documentation in one place: a single binder with glove lot records, cycle logs and spore test results is easier to audit than three systems. Build the cycle portion with the log generator.
Which glove should a clinic stock for routine exams?
Match the glove to the task. A 4.0 mil powder-free nitrile glove covers routine examination and general clinic work. A 4.5 mil fully textured glove, such as the Robust nitrile examination glove, gives more grip for wet work and longer procedures. Sterile surgical gloves are a separate product with their own standard and should not be substituted for exam gloves in a sterile field. Stock two SKUs, not five, and standardise sizing so staff do not double-glove to compensate for a poor fit.
Related reading
- Do exam gloves have to meet AQL pinhole limits?
- Exam gloves and surgical gloves: what a clinic should stock
- Case review: a Moncton clinic cut glove use by sizing staff at the door
Download the printable sterilization log, or build one with the log generator. Ask a Compliance Specialist at our consultation desk. Ordering for a clinic, lab or care home? Wholesale and multi-site ordering covers account setup for institutional buyers. Start with a five-strip biological indicator sample request when you are standardising supplies across sites. Reselling? become a distributor.
Frequently Asked Questions
Are exam gloves Class I or Class II in Canada?
Examination gloves are Class II medical devices in Canada, which means the manufacturer holds a medical device licence and the importer or distributor holds a Medical Device Establishment Licence.
Do exam gloves need 510(k) clearance in the United States?
Examination gloves are exempt from premarket notification under 21 CFR 880.6250, but the establishment must register and list the device and the product must meet the applicable ASTM performance standard. Surgical gloves are Class II and do require clearance.
What does AQL 1.5 mean on a glove box?
It is the acceptance quality limit applied to the watertight test for a lot. It is a statistical lot limit, not a guarantee that every individual glove is free of pinholes, which is why lot test reports matter.
Do Canadian glove labels need French text?
Yes. Canadian medical device labelling requires English and French on the label and instructions, so an English-only box is a compliance problem for the Canadian distributor even when the gloves meet the physical standard.
CliniEco Medical is a licensed medical device establishment (MDEL #35334).