Here’s how we ensure our masks’ quality:
A certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards.
There are a lot of invalid CE certifications out there, so we wrote an article to teach you how to identify valid CE Certification.
Our factory’s masks are certified as medical devices and can be used in hospitals.
Our certification is issued by ENTE CERTIFICAZIONE MACCHINE SRL under notified body number : 1282 You can check the information on the European Commission website.
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a "certificate" for products regulated by the Food and Drug Administration (FDA). A certificate is a document prepared by the FDA containing information about the product's regulatory or marketing status.
There are also a lot of unqualified FDA certifications, but you can check ours on the FDA website. Establishment Registration or FEI Number : 3004105221.
Why the certifications are different compared with KN95 product listed on our website?
Each product is produced under different standard based on the usage of the product.
The surgical mask is considered as medical supplies which is medical grade can be used for doctors in hospitals.
Surgical masks need to be tested on its filter and fit performace. We provide two reports which are conducted by two different organization to ensure the quality.
The english report is done by NQA which is part of NTS, the leading independent provider of environmental simulation testing, inspection and certification services in the USA. NTS serves a broad range of industries, including the civil aviation, space, defence, nuclear, telecommunications, industrial, electronics, medical and automotive markets.
The chinese report is done by Hubei Medical Device Supervision and Inspection Division which is a national quality inspection agency.
Click here to see details.
In China, all businesses need to have a registration proving their legitimacy.
This license will additionally state the scope of business operations.
The factory we work with is qualified to manufacture masks for medical usage, can be used for hopistals.
This affects exporting from China. Any factory that fails to provide this license proving the scope of their business will be unable to pass customs clearance (as of the new rule implemented on April 1st).
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction.
The factory we use complies with the following:
Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
50 pcs per box
Min order 6 boxes (300 pcs) will be packed into a master carton.
Bookairfreight is a logistics technology platform, with partners in more than 50 countries.
- Transit time 8 - 10 biz days
- Tracking number provided
- We handle customs clearance
Reciever will be paying the tax and duty if needed.
Tax and duty rate will be subjected to different countries regulation.
This mask can be used for hospitals.
If you want to donate to hospitals, please contact us at firstname.lastname@example.org directly. Donations usually don't require tax and duty, so we will operate under a different exporting and importing process.