SINGAPORE - A company that produces items such as medical disposables was charged in a district court on Thursday (Jan 20) after it allegedly made more than 430,000 three-ply surgical masks without a manufacturer's licence.

First N-Lab is said to have manufactured the masks labelled "N-Lab" some time between October 2020 and April last year.

According to court documents, masks are Class A medical devices under the Health Products Act.

The Health Sciences Authority (HSA) states on its website that medical devices "have a physical or mechanical effect on the body, and are used to diagnose, alleviate or treat medical conditions".

It added that they may also be used to measure or monitor specific functions of the body.

The HSA also said that medical devices are classified into four risk classes - A to D - with Class A being the lowest-risk class.

Items such as bandages, wheelchairs and surgical masks fall under Class A.

Class D medical devices include pacemakers, heart stents and breast implants.

First N-Lab is expected to plead guilty next month.