Our medical examination gloves are Health Canada registered Class II Medical Devices.  According to the Canadian Medical Device Regulations, effective July 15, 2006, all manufacturers for Class II medical devices must hold a valid ISO 13485:2003 certificate as evidence of compliance to the appropriate regulatory quality system requirement.

International Organization for Standardization (ISO)

ISO is a worldwide federation of national standards body.  Health Canada accepts quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars.  Chartwell Industries (Canada) Ltd. is certified and registered with the ISO 13485:2003 standard.  All employees understand and work in accordance to the details of this program as our policy is based on this quality assurance standard.  This is the promise that we make to our staff and customers. 

Gloves that we recommend for the use in the food service industry have been accepted by the Canadian Food Inspection Agency (CFIA) as safe for contacting with food.