A few days ago, the medical surgical mask produced by Jiangxi 3L group was registered with FDA 510 (k). This is another kind of mask product of 3L group company after disposable medical mask and medical protective mask (N95), which has been registered by FDA!

FDA's technical requirements for surgical masks

The main components of the medical surgical mask include the main body of the mask, the bridge of the nose and the ear hook. The mask body is generally composed of three layers, namely the outer layer of non-woven fabric, the inner layer of non-woven fabric and the middle filter layer. The filter layer is usually made of meltblown cloth material.

FDA's technical requirements for medical surgical masks usually include two aspects: one is the filtration and protection performance of the products. The other is the biocompatibility of all materials.

1. Filtration and protection performance of products

1) Anti penetration ability of liquid splashing;

2) Particle filtration efficiency PFE;

3) Bacterial filtration efficiency BFE;

4) Respiratory impedance delta P test;

5) Flammability index.

2. Biocompatibility of materials

Biocompatibility is the key index of material safety. Generally, only cytotoxicity, sensitization and skin irritation need to be tested for products in contact with human skin. But for different parts of the mask, due to the different materials, there are non-woven fabrics, rubber band earrings, plastic or metal nose bars, which need to be tested separately to provide evidence of safety. If the color of the mask is different, the biocompatibility test also needs to be carried out separately, because different pigments may lead to different biocompatibility.

In addition to the above, FDA's main technical requirements for medical surgical masks also include the appearance, size, sterilization status and label requirements of the products.

Novel coronavirus pneumonia has been a key force in the development of 3L. It has been the first to develop more than 10 years ago to develop melted non-woven medical surgical masks in China. It has made outstanding contributions to influenza A, B, SARS, avian influenza and new crown pneumonia this year.