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.
As part of our commitment to social corporate responsibility and our obligation to ethical trade and business, we became a member of Supplier Ethical Data Exchange ("Sedex") on 9 June 2019.
Since joining, our subsidiary Central Medicare has undergone two Sedex Members Ethical Trade Audit ("SMETA") audits conducted by independent auditors, in June 2019 and November 2019.
SMETA is an ethical audit methodology developed by Sedex that covers Sedex's four pillars of labour, health and safety, environment and business ethics. SMETA audits are governed by, among others, the Ethical Trading Initiative Base Code ("ETI Base Code") and local law.
We completed our SMETA 6.1 audit conducted by UL in November 2019. This audit indicated, among other things, that our labour practices are in line with the ETI Base Code with the exception that our employees work an average of 66 hours per week. While this is allowed under national law, it is more than the 60 working hours within any seven-day period normally permitted under the ETI Base Code.
However, we believe that we have met the criteria for an exception under the ETI Base Code which allows our working hours to exceed 60 hours within any seven-day period, namely that (a) this is allowed by national law, (b) this is allowed by a collective agreement freely negotiated with a workers' organisation representing a significant portion of the workforce, (c) appropriate safeguards are taken to protect the workers' health and safety, and (d) we are able to demonstrate that exceptional circumstances apply such as unexpected production peaks, accidents or emergencies.
