Important regulatory considerations for the supply of medical gowns: Guidance to industry
Find information on the requirements for getting medical devices authorized in Canada on the medical devices page.
The purpose of this document is to provide regulatory information with regard to medical gowns.
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In Canada, all medical gowns are Class I medical devices. Medical devices are classified into four groups (Class I, II, III and IV) based on their risk to health and safety. Class I devices present the lowest potential risk (e.g., gauze bandages), while Class IV devices present the largest potential risk (e.g. pacemakers). Health Canada licenses all Class II, III and IV medical devices imported, advertised and sold in Canada.
An establishment license is required for the importation or sale of Class I medical devices. Unlike the higher risk Class II-IV medical devices, there is no pre-market review for Class I and these devices are not subject to the quality management system requirements under the Medical Devices Regulations and thereby do not require an audit under the Medical Device Single Audit Program. Class I devices can be manufactured by companies that hold a Medical Device Establishment Licence (MDEL). Medical gown manufacturers authorized in Canada are listed in the Medical Devices Establishment Licence Listing database.
Information on how to obtain a Medical Device Establishment Licence for medical gowns
Fast-tracking approval of medical gowns in Canada
Canada is also speeding up the importation and sale of medical devices used to diagnose, treat, mitigate or prevent COVID-19.
- Manufacturers can submit an application under the provisions of the Interim Order for an authorization to import or sell their COVID-19 medical device. This application does not require fees and is helpful for gown manufacturers who would otherwise not come to the Canadian market.
To submit an application for authorization under the Interim Order, contact the Medical Devices Directorate at devicelicensing-homologationinstruments@hc-sc.gc.ca.
For information about the licensing or authorization of medical devices in Canada, contact the Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca.
- Health Canada is also fast-tracking the MDEL application process for companies that want to manufacture, import or distribute Class I medical gowns.
Companies that need an MDEL application fast-tracked should:
- complete the MDEL Application Form (FRM-0292)
- indicate in the subject line of the email: URGENT COVID-19 MDEL application for "-name of company"
- email the completed MDEL application form to hc.mdel.application.leim.sc@canada.ca
For more information, refer to Guidance on Medical Device Establishment Licensing (GUI-0016).
Current MDEL holders who want to import or distribute gowns with non-compliant labeling into Canada
Manufacturers, importers and distributors that hold an MDEL, may be able to import gowns with non-compliant labelling into Canada. Examples include:
- not having a bilingual label
- having the distributor contact information on label instead of the manufacturer's contact information
To import these gowns, manufacturers and importers should:
- complete the Medical devices for exceptional importation and sale request form
- email the completed form along with a copy of the product label to medicaldevices.covid19.instrumentsmedicaux@hc-sc.gc.ca
- Health Canada will review the request and inform you of our decision to add to the list.
- Once on the list, importers must notify Health Canada using the COVID-19 medical device Exceptional importation and sale notification form to import a designated device at least 5 calendar days before the day on which the device is imported. Notifications should be sent to: medicaldevices.covid19.instrumentsmedicaux@hc-sc.gc.ca.
About medical gowns
Medical gowns are used in a variety of health care settings, such as Emergency Departments, Intensive Care Units, and clinics. An appropriate type of gown is selected within the context of the setting and needs of health care professionals and patients.
There are two main types of medical gowns: isolation gowns and surgical gowns. They are both Class I medical devices. It is important to note that the product names of gowns are not standardized. These products may also be called procedural gowns, operating room gowns, or non-surgical gowns.
Sustainability
The Government of Canada encourages manufacturers to consider the use of recycled fibres/fabrics, recyclable and/or sustainable components in the development of medical gowns.
Levels of risk
Regardless of how the product is named, the product labeling describes the intended use, and it is necessary to identify the desired level of protection based on the level of risk.
There are four levels of risk that can be broken down into two categories: Low Risk (Level 1 and Level 2) and High Risk (Level 3 and Level 4):
| Gown classification | Level of risk | Examples of work | |
|---|---|---|---|
| Low risk | Level 1 | Minimal | Standard precautions; Simple procedures |
| Level 2 | Low | Minimally invasive surgery | |
| High risk | Level 3 | Moderate | Open gastrointestinal surgeries |
| Level 4 | High | Open cardiovascular procedures; Trauma procedures |
Types of gowns
Isolation gowns
Isolation gowns are protective apparel used to protect the clothing of health care professionals, visitors, and patients from the transfer of microorganisms and body fluids in patient isolation situations.
Surgical gowns
Surgical gowns are sterile textile gowns worn by health care professionals who are performing activities in a sterile environment.
Standards for medical gowns
The section below describe the international standards recognized by Health Canada. There are standards for both the material integrity of gowns, as well as for the protective nature they provide.
Material integrity
These are standards that relate specifically to the integrity of the material used to make gowns including tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission. Health Canada accepts conformance with the American Society for Testing and Materials (ASTM) F2407 which is an umbrella document that covers the following standards:
- Tensile Strength: ASTM D5034, ASTM D1682
- Tear resistance: ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM D1424
- Seam Strength: ASTM D751 (stretch woven or knit)
- Lint Generation (ISO 9073 Part 10)
- Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75
Risk prevention
The standards listed below describe barrier performance with respect to penetration by liquids or liquid-borne pathogens. This ensures the prevention of transmission of pathogens and is intended for use in health care facilities.
Health Canada recognizes the following standards (summarized in the below table):
- Canadian Standards Association (CSA): CSA Z314
- American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70
- The European Standards EN: EN 13795-1
The World Health Organization also recognizes the EU Personal Protective Equipment (PPE) Regulation 2016/425 and EU MDD Directive 93/42/EEC for single use gowns.
| North American Standards | European equivalencies | |||
|---|---|---|---|---|
| CSA Z314 (Canada) and American National Standards Institute (ANSI) ANSI PB70 (USA) | EN 13795-1, for Gowns | |||
| Classification | Standard / Testing | Classification | Standard / Testing | |
| Lower risk | Level 1 Minimal water resistance (some resistance to water spray) | AATCC 42 - Water penetration ≤ 4.5 g AATCC 127 - Hydrostatic pressure N/A | Standard performance | ISO 811 – Hydrostatic pressure
|
| Level 2 Low water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure) | AATCC 42 - Water penetration ≤ 1.0 g AATCC 127 - Hydrostatic pressure ≥ 20cm water column | |||
| Higher risk | Level 3
Moderate water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure) |
AATCC 42 - Water penetration ≤ 1.0 g AATCC 127 - Hydrostatic pressure ≥ 50cm water column > |
High performance | ISO 811 – Hydrostatic pressure
|
Expired gowns
Medical gowns may be disposable or reusable.
It is not recommended to use expired disposable medical gowns without confirming that they are still fluid resistant according to AATCC Test Method 42 for gowns of level 1, 2 and 3, or AATCC Test Method 127 for gowns of level 2 and 3.
Reusable (washable) medical gowns may be cleaned after each use and safely reused. Reusable gowns are required to meet manufacturer's instructions with respect to sterility and laundering requirements for healthcare settings. This includes the number of times gowns can be laundered to maintain performance, safety, and effectiveness. If there is no date available on the gown label or packaging to indicate a manufacturer-designed shelf life, facilities should contact the manufacturer.
Reusable gowns can be used beyond their recommended life span provided they are free of damage. Expired gowns should be visibly inspected for damage prior to use. Indications of damage may include odours or noticeable/heavy soiling, staining, or spotting (for example, signs of mould).
Expired gowns, whether disposable or reusable, can also be used for training and demonstration purposes in cases where protective barriers are not needed.
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