
Compliance
Excellence is at the core of everything we do. Our rigorous quality standards, comprehensive management systems, andcommitment to regulatory compliance have earned certification and recognition from respected international governing andaccreditation bodies.
Health Canada: MDEL
Health Canada: MDL
ISO 9001 : 2015
ISO 13485 : 2016
Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination and Sterile Surgical Gloves
Directive 93/42/EEC on Medical Devices, Annex V
Natural (Latex) and Synthetic Latex (Nitrile) Surgical Gloves
NextTech Certificate of Compliance
ISO14644 compliance
Medical Device Act2012 (ACT 737) Establishment Licence
Manufacturer
MDSAP (US, Canada, Japan, Australia, Brazil)
Certified 510K Premarket Approval (FDA)
PPE Module D (CE)
SEI NFPA (Registered Facility)
Member of SMETA
