A company that produces medical disposables, Firest N-Lab, was charged on 20 January for allegedly making more than 430,000 surgical masks without a valid manufacturer’s license.
The company allegedly manufactured the three-play surgical masks labelled “N-Lab’ between October and April 2021.
Under the Health Products Act, masks are categorised as Class A medical devices which requires a license.
First N-Lab is expected to plead guilty in court at the next case hearing next month.
Medical devices
According to the Health Sciences Authority (HSA) medical devices are defined as having a “physical or mechanical effect on the body, and are used to diagnose, alleviate or treat medical conditions.”
They are classified under fours categories of risk classes, from A to D, with D being the highest risk class.
For example, low-risk items such as bandages and surgical masks are categorised under class A while high-risk items such as pacemakers and heart stents are categorised under class D.