We are certified to the following standards to meet the stringent demands of the glove manufacturing industry regulatory bodies and the end user markets.
Quality management system for manufacture and supply of non-sterile Natural Rubber Latex and Nitrile examination gloves, powdered and powder free.
ISO 13485 : 2016 + AC : 2012
Manufacture and supply of non-sterile powered and powder free latex and nitrile examination gloves.
Manufacture and supply of sterile powdered and powder free latex surgical gloves.
ISO 13485 : 2003 + Cor. 1 : 2009
Quality management system for manufacture and supply of non-sterile, Natural Rubber Latex and Nitrile examination gloves, powdered and powder-free medical gloves for healthcare industry.
ISO 13485 requirements reach beyond the normal quality system standards of FDA, QSR and ISO 9000.
These standards are used when an organisation needs to demonstrate its ability to provide medical devices and related services, as required by the Medical Device Directive of European Union.
ISO 13485 standards ensure that products consistently meet quality standards, and customer and regulatory requirements.