We are continuously raising the bar on
quality, safety and efficiency
Our gloves are accredited by and/or meet standards set by the U.S. FDA, ASTM, the European Union and the National Medical Products Administration (“NMPA”) in China.
In addition, the quality management systems we use in our manufacturing process are certified under the Medical Device Single Audit Program (“MDSAP”), which is an audit that satisfies the requirements of multiple regulatory jurisdictions.
The majority of our products have been cleared by the FDA for marketing and distribution in the United States. We are registered as a Foreign Medical Device Manufacturer with the Pharmaceuticals and Medical Devices Agency in Japan, which allows us to sell our gloves into Japan through authorised distributors.
In 2020, we registered several of our gloves under Section 5(1) of Act 737 with the Malaysian Medical Device Authority (“MDA”), which allows us to commercially distribute them in Malaysia, though we currently have no plans to do so.