Smart Glove has been accredited the highest recognized certification of ISO 9001: 2015, EN ISO 13485:2016, ISO 13485: 2016 by an SCC accredited CMDCAS registrar, and EC certificate, complying with Canadian Medical Device Regulation, and FDA Quality System Regulation (QSR) to ensure consistent glove performance. Our medical product range allowed to market in the United States by the FDA through 510(k) process.
All gloves are manufactured and inspected in strict compliance with Good Manufacturing Practices, surpassing those of the industry standard established by the American Society for Testing and Material (ASTM), EN Standard and FDA requirement. Our gloves fulfilled CE mark, UL certified according to NFPA 1999-2013 Edition, Standard on Protective Clothing for Emergency Medical Operations, fulfilled EN Food Contact Regulation (EC) No. 1935/2004, Medical Device Directive 93/42/EEC and Personal Protective Equipment EU Regulation 2016/425.
All gloves are quality guaranteed and gone through a stringent inspection internally and independent third party prior to each shipment. It indicates commitment from Smart Glove to continually exceeding Acceptable Quality Level (AQL), providing you with maximum barrier protection and consistently deliver our product that exceed customers’ quality requirements.