Important regulatory considerations for the supply of medical gloves during the COVID-19 outbreak: Guidance to industry

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The purpose of this document is to provide regulatory information with regard to disposable medical gloves during the COVID-19 outbreak.

Medical gloves are essential during the COVID-19 outbreak. They help slow the spread of the disease in Canada and protect health care providers. Medical gloves form part of the personal protective equipment (PPE) that are used to protect health care professionals and patients from the spread of infection. For general information on medical gloves and medical glove standards, please refer to the About Medical Gloves section below.

In Canada, all medical gloves are Class II 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., elastic 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, sold and advertised in Canada. Class I medical devices are authorized through a medical device establishment license.

To manufacture and sell medical gloves (Class II), you need a medical device licence from Health Canada. Before issuing a licence, Health Canada verifies that the device meets the requirements for safety and effectiveness and complies with the standards for a certified quality management system. Medical glove manufacturers licenced in Canada are listed in the Medical Devices Active Licence Listing.

Information on how to obtain a Class II medical device licence for manufacturers of medical gloves.

To import and distribute licensed medical gloves (Class II) in Canada, you need a Medical Device Establishment Licence (MDEL), unless you are a:

Get more information on MDELs and exemptions.

Fast-tracking approval of medical gloves in Canada

Canada is also speeding up the importation and sale of medical devices used to diagnose, treat, mitigate or prevent COVID-19.

On March 18, 2020, the Minister of Health approved an interim order, which means 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 medical glove manufacturers who would otherwise not come to the Canadian market. Health Canada reviews all COVID-19-related submissions and applications as quickly as possible without compromising patient safety.

To submit an application for authorization under the interim order, please contact the Medical Devices Directorate at hc.devicelicensing-homologationinstruments.sc@canada.ca.

For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca.

Labelling considerations

Labelling of medical gloves

The Medical Device Regulations and the Interim Order specify how to label medical devices. If you manufacture medical devices, you must clearly explain the intended use of a device if it is not clear. You can accomplish this using specific words and images. For example:

These labels are necessary because not all disposable gloves are manufactured or sold for use as medical gloves. Consumers also use disposable gloves in car repair shops or for personal use in their homes.

Non-medical gloves

Non-medical gloves are not subject to the Regulations and should not be mistaken for medical gloves. Non-medical and industrial-use gloves must not give the impression they can be used for medical purposes. If they were used for medical procedures, they could pose a health risk to Canadians.
If non-medical disposable gloves are manufactured, the label and advertising should not say or suggest the gloves have a medical use. It is also important that the brand or company name associated with the gloves does not imply a medical use.

Current MDEL holders who want to import or distribute medical gloves with non-compliant labelling into Canada

Importers and distributors that hold an MDEL, may be able to import medical gloves with non-compliant labelling into Canada. Examples include:

To import these medical gloves, the gloves must have a device license and importers and distributors should:

Medical glove donation

Note: A separate guidance is currently under development for the donation of PPE such as medical gloves. The guidance will be posted shortly and a link in this document will be provided.

About medical gloves

Disposable medical gloves are used in a variety of health care settings, such as Emergency Departments, Intensive Care Units, and medical clinics. Medical gloves can include examination gloves (non-sterile or sterile), surgical gloves, and chemotherapy gloves (not covered in this document). An appropriate type of glove is selected within the context of the setting and needs of health care professionals and patients.

Medical gloves may be made of latex, vinyl, synthetic polymer, or nitrile. They may also be sterile or non-sterile. For example, disposable, non-sterile, nitrile or vinyl gloves in first aid kits are medical gloves. They protect both the patient and the wearer.

Standards for medical gloves

Health Canada advises organizations who are manufacturing medical gloves to consult the following standards throughout the design and testing stages and choose the standard that is appropriate for their product. Alternatively, manufacturers can submit data to Health Canada establishing equivalency using their own test methods.

For information on how to submit equivalency data, please contact the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca.

Standards recognized by Health Canada:

Surgical rubber gloves

Medical examination gloves – rubber latex

Medical examination gloves – nitrile rubber latex

Medical examination gloves - poly (vinyl chloride)

Medical glove test methods

World Health Organization standards

The World Health Organization also recognizes the following standards for certification of gloves:

Gloves, examination, non-sterile

Gloves, examination, nitrile, powder-free, non-sterile, single-use Gloves should have long cuffs, reaching well above the wrist, ideally to mid-forearm. Sizes: small, medium, large.

Standards

Gloves, examination or surgical, sterile

Gloves - surgical or examination - nitrile, powder-free, sterile, single-use. Gloves should have long cuffs, reaching well above the wrist, ideally to mid-forearm. Sizes: small, medium, large.

Standards

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