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Certifications

Quality standards, management systems and exemplary regulatory compliance.

Our Certificates

Our quality standards, management systems and exemplary regulatory compliance, all contribute to the global success of the company. Our capabilities have been assessed and certified by the following international governing bodies.

ISO 9001 : 2015

ISO 13485 : 2016

Brightway (Plant 1), Laglove, Biopro

Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination and Sterile Surgical Gloves

Directive 93/42/EEC on Medical Devices, Annex V

Brightway (Plant 1), Laglove, Biopro

Natural (Latex) and Synthetic Latex (Nitrile) Surgical Gloves

NextTech Certificate of Compliance

Brightway

ISO14644 compliance

Medical Device Act2012 (ACT 737) Establishment Licence

Brightway, Laglove, Biopro

Manufacturer

MDSAP (US, Canada, Japan, Australia, Brazil)

Certified 510K Premarket Approval (FDA)

PPE Module D (CE)

SEI NFPA (Registered Facility)

Member of SMETA