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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

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