1、 Why do masks need FDA certification?

 

N95 mask and medical mask belong to class II medical devices in the United States, and 510 (k) application is required. And other types of masks belong to class I medical devices, which can be registered and certified by enterprises. Therefore, no matter what type of masks are under the jurisdiction of FDA (food and Drug Administration of the United States), they must be FDA certified for export to the United States.

 

2、 Procedure of FDA certification of respirator

 

Step 1: identify U.S. agents and medical device categories

Step 2: select the right pre IPO submission

Step 3: prepare appropriate materials for submission before listing

Step 4: the enterprise pays the official annuity to the FDA

Step 5: submit pre marketing materials to FDA

Step 6: complete enterprise registration and device listing

 

 

3、 Cost of FDA certification of masks

 

The specific cost shall be determined according to the specific conditions such as the model parameters of the specific products. The relevant specific cost can be confirmed by contacting our staff.

 

4、 Classification and protection index of masks

 

Masks can be divided into two categories: respiratory protective masks and surgical masks, which can be referred to as protective masks and medical masks for short. The protective indexes of medical masks generally include the following aspects, respectively:

 

Bacterial filtration efficiency (BFE): the larger the value is, the better it is, representing the resistance to bacteria; the diameter of bacteria is generally 0.2-2 μ M

Particle filtration efficiency (PFE): the larger the value is, the better the value is, which represents the blocking ability to micro particles; here, the diameter of micro particles generally refers to particles smaller than the diameter of bacteria; therefore, if the particle filtration efficiency is high, the bacterial filtration efficiency must be high

Synthetic blood penetration resistance: the higher the value is, the better it is, representing the resistance to liquid splashing

Pressure difference: the higher the value is, the better it represents the pressure difference inside and outside the mask. The higher the pressure difference, the better the sealing performance and the higher the protection ability.

 

The two focuses are different. Respirators are more focused on high particle filtration efficiency, while surgical masks are more focused on the protection of liquids, such as blood splashes (high synthetic blood penetration resistance); however, respirators are often in short supply when there is a major epidemic, and surgical masks can also be used as the most basic means of respiratory protection when necessary.

 

 

5、 Standards and grades of masks in the United States

 

The standard of respirator in the United States is bnoish / National Institute of occupational safety and health.

Pay attention to the protection level as follows:

N95: PFE >= 95%

N99: PFE >= 99%

N100: PFE >= 99%

 

The standard of American medical mask is ASTM f2100.

Pay attention to the protection level as follows:

Level 1 (BFE > 95%, PFE > = 95% @ 0.1 micron, pressure difference < 4.0, liquid resistance = 80 mmHg)

Level 2 (BFE > 98%, PFE > = 98% @ 0.1 micron, pressure difference < 5.0, liquid resistance = 120 mmHg)

Level 3 (BFE > 98%, PFE > = 98% @ 0.1 micron, pressure difference < 5.0, liquid resistance = 160 mmHg)

 

 

6、 Advantages of CMC mass inspection mask FDA certification service

 

CMC is the first agency engaged in FDA certification of respirators and medical masks in China. With long-term development of respirator standards, CMC has unique experience and experience in FDA certification of respirators. The main performance of the certification requirements and processes can be fully controlled.

 

So if you are having a headache about how to apply for FDA certification of respirators, you may as well call us to communicate with us. We will provide the most thoughtful and cost-effective certification scheme for you to choose.