Cleanroom Nitrile Gloves

Smart Glove Group has been accredited the highest recognized certification of ISO 9001: 2008, EN ISO 13485:2003, ISO13485: 2003 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 1999-2008 Edition, Standard on Protective Clothing for Emergency Medical Operations, fulfilled EN Food Contact Regulation 02/72/EC, Medical Device Directive 93/42/EEC, Personal Protective Equipment Directive, 89/686/EEC, and Standard Malaysian Glove by Malaysian Rubber Board.