Face Mask Buyers Need to Know before Import

1. Types of masks

Masks can be divided into two categories: medical / non-medical. Medical face masks are mainly used for medical protection, subdivided into three types: medical protection, medical surgery, and disposable medical; non-medical masks are also called personal protective masks, and are divided into two types: anti-particulate and daily protection according to the usage scenario.

2. How to distinguish medical and non-medical masks?

2.1 Check the mask structure. Masks with filter valves are generally not medical masks. The Chinese standard for medical protective masks GB19803-2010 clearly stipulates that “medical masks should not have a breathing valve”, which can avoid the exhalation of droplets and microorganisms through the breathing valve and reduce the infection of others. Civil masks are allowed to have an exhalation valve. The exhalation valve can reduce the exhalation resistance, which is suitable for long-term workers in industrial sites;

2.2 Distinguish by mask packaging
If the words “medical” and “surgical” are on the box of masks for regular sales, they are generally medical masks;

3.Standards of masks in different countries

Export to the United States:
Medical masks are medical devices in the United States and are subject to ASTM F2100. They are managed by the US FDA and must be registered through the 510K or other channels recently announced by the FDA. They can only be marketed in the US after obtaining factory registrations and medical device listings. Non-medical masks need to be registered by NIOSH;

Export to the EU:
Medical masks belong to Class I devices in the EU, which are classified into non-sterile and sterile. They are affixed with the CE in accordance with 93/42 / EEC (MDD) or EU2017 / 745 (MDR). The corresponding standard is EN14683.

Non-medical masks exported to the EU are not medical devices, but meet the requirements of EU2016 / 425 (PPE). CE certification and certification are issued by authorized notified bodies. The corresponding standard is EN149.