1、 Importance of mask FDA registration

 

The mask is a kind of sanitary product, which is generally used to filter the air entering the mouth and nose by wearing it on the mouth and nose, so as to block harmful gases, smells and droplets from entering and leaving the mouth and nose of the wearer. It is made of gauze or paper, etc. Masks have a certain filtering effect on the air entering the lungs. When respiratory infectious diseases are prevalent, and when working in dust and other polluted environment, wearing masks has a very good effect.

 

The export of masks to the United States requires FDA registration, because the FDA is authorized by the U.S. Congress or the federal government and is the highest law enforcement agency specialized in food and drug management. The FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical devices and radiation products produced or imported in the United States.

2、 FDA registration process of respirator:

 

1. Consultation: the applicant shall provide product information (product picture, product manual, business license of the applicant, etc.) and all products and materials required to apply for FDA.

 

2. Quotation: according to the information provided by the applicant, the technical engineer will make an evaluation, determine the items to be tested and make a quotation to the applicant.

 

3. Preparation of opening data: the applicant shall fill in the test application form and test samples after confirming the quotation.

 

4. Sample testing: testing will be performed in accordance with applicable FDA standards.

 

5. Issue report: provide FDA certification report after the test.

 

3、 FDA registration cycle of masks: 7-14 days in general.

 

Four, mask FDA registration number reference five, medical mask FDA registration precautions:

 

1. May include masks labeled as surgical, laser, isolation, dental or medical procedure masks.

 

2. Can help prevent exposure to microbes, body fluids and large particles in the air.

 

3. Designed to cover the mouth and nose loosely, but not in a size suitable for personal use.

 

4. May help to prevent patients from contacting the wearer's saliva and respiratory secretions.

 

5. Have specific instructions, warnings and restrictions for use in a healthcare environment.

 

6. Whether NIOSH is certified.