Personal protective equipment against COVID-19: Medical gloves
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Importance of medical gloves
Medical gloves are essential for health care providers during the COVID-19 outbreak. As a personal protective equipment (PPE), they help protect health care providers by providing a barrier to help prevent potential exposure to infectious disease. They also help slow the spread of the disease in Canada.
Health care providers use medical gloves in a variety of settings, including emergency departments, intensive care units and medical clinics. Medical gloves may be made of latex, vinyl, synthetic polymer or nitrile. They may also be sterile or non-sterile. For example, medical gloves include:
- surgical gloves
- chemotherapy gloves
- non-sterile or sterile examination gloves
- disposable, non-sterile, nitrile or vinyl gloves in first aid kits
They protect both the patient and the wearer.
Medical gloves distributed and sold in Canada
In Canada, all medical gloves are classified as Class II medical devices. This means they meet design, testing and manufacturing standards set by Health Canada. Non-medical gloves are not subject to the Medical Device Regulations and should not be mistaken for medical gloves. If they were used for medical procedures, they could pose a health risk to Canadians.
To import and distribute licensed medical gloves in Canada, companies need a medical device establishment licence (MDEL). There are exemptions for:
- retailers
- health care facilities (as defined in the Regulations)
- manufacturers that have a medical device licence (MDL)
- manufacturers that have interim order (IO) authorization
The COVID-19 pandemic has created an unprecedented demand for medical gloves. To meet the demand, Health Canada is allowing the importation and sale of medical gloves that don’t meet labelling requirements. Guidelines outline how manufacturers, importers and distributors that hold an MDEL can import medical gloves with non-compliant labelling into Canada.