Quality Certification

Medical Device Authority

ISO 13485:2016

Medical Devices Quality Management System

ISO 9001:2015

Quality Management System

ASTM D6319

Standard for Nitrile Rubber Gloves Medical Application

EN455

Requirement and Testing of Gloves for Medical Work

EN374

Protective gloves against chemicals and micro-organisms

Conformitè Europëenne (CE) Mark

FDA 510(K)

Therapeutic Goods Administration (TGA)

Approval to supply Nitrile examination/treatment glove, non-powdered in Australia