GST epidemic prevention materials special compliance services-masks

GST provides a one-stop testing and certification service for related medical and protective materials (e.g. masks, protective clothing, forehead temperature gun, goggles, etc.).

GST, as a third-party testing institution with complete qualification, complete experimental capacity and rich practical experience, will do its best to assist enterprises to provide targeted, one-stop testing and certification services for relevant medical and protective materials (such as masks, protective clothing, forehead temperature gun, goggles, etc.).The market requirements and service details of related products are as follows:






The market demand


Medical and

Personal protective

Common testing standards:

Gb19083-2010 technical requirements for medical protective masks

Yy0469-2011 technical requirements for surgical masks for medical use

GB/T 32610-2016 technical specification for daily protective masks

GB 2626-2006 respiratory protection self-absorption filter anti-particulate respirator

Common test items:

1. Physical and chemical indicators

2. Microbial indicators

3. Toxicological allergic index

2 weeks




The market demand



Common surgical masks belong to class II medical devices in the us FDA, which requires FDA factory registration and 510 (k) application before marketing. The application process is as follows:

1. Conduct product testing

2. Prepare 510k technical documents and submit them to FDA for review

3. Obtain a 510k approval letter from FDA

4. Complete the factory registration and device listing.

6-10 months

Personal protective

A NIOSH certification is required and certification applications must be carried out in accordance with NIOSH guidelines.The certification is carried out by NIOSH's NPPTL laboratory.

The process is as follows:

1. Send samples to NIOSH lab for testing

2. Submit technical materials for document review

3. NIOSH certification

2-3 months




The market demand



The European standard for surgical masks is EN14683, which is required to meet the requirements of the European Union (EU) 2017/745 (new version of MDR for medical devices).

Certification process:

1. Prepare technical documents

2. Provide test reports

3. Provide a declaration of compliance

4. Appoint an authorized representative of the European Union to complete the registration.

2-3 months

Personal protective

According to standard EN149, the requirements of the eu (E U) 2016/42 personal protective equipment directive (PPE) need to be met.

Certification process:

1. Type test report of the product

2. Review of technical documents

3. Factory quality system review

4. Issue a CE certificate.

1 to 2 months


GST welcomes all customers to consult us on the testing, CE certification and FDA registration of anti-epidemic substances. I believe that your work and my work will contribute to the fight against the epidemic in the world.




Follow WeChat
Learn the latest news


Floor 1-5, Building C10, Xin'an Second Industrial Zone, Guxiang, Xixiang, Baoan District, Shenzhen

Shenzhen General Standard Testing Services Co., Ltd.

sitemap      contact