All manufacturing facilities have recognised approval and/or accreditation for the following:
EU 89/868/EEC 11B: All Complex Design (Category III) products are audited regularly by Notified Body SGS alongside the ISO 9001 QA system in accordance with Article 11B of the PPE Directive.
FDA 510(k) Class 1 Medical Devices
Component materials comply with all relevant federal regulations for food contact.
Classified by Underwriter’s Laboratory, National Fire Protection Association, 1999 Standard on Protective Clothing for Emergency Medical Operations, 2003 Edition.