Medical Mask Purchasing, Risk Control Series No.2 – Verification of Masks Quality: Test Reports and Test Report’s Limits

Risks do exist in the whole process of purchasing medical masks, there are many aspects that need to pay attention to before you make the payment. They are:

1. Company reputation, certifications?

Always do business with a company or brand that has a good reputation in their main business, qualified certifications also can provide evidence that they can be trusted, Such companies are much less likely to be speculators than those who take advantage of the opportunity to make a fortune and disappear because they know the epidemic will be beaten and their main business will back to normal eventually. Check this article showing you several ways to evaluate the risk of a company’s reputation.

2. Qualified manufacturer, has a true medical device registration number?

We have listed methods to validate the manufacturer or company, whether they are qualified to produce medical face masks, check this post for more details.

1. Masks Quality, how to prove?

This is the main top of today, let’s dive in.

Before we talking about the way to validate the mask quality, first we should know what makes masks qualified, to make it simple, We have summarized the two most important dimensions:

• Anti-virus performance
• Easy breathability

Remember good quality masks always has relatively easy breathability and good anti-virus performance.

So how can we know exactly about these two performances?

One way is asking the supplier to send you the test report of their masks;

Another solution will be committing a third-party mask testing agency to conduct the test according to specific testing standards, for example, China has 5 common masks standards for different purposes.

For both solutions, you will need to read the test report, either from your mask supplier or for the mask testing labs.

Key Info. You Should Read from the Mask Testing Report

For mask wholesaler who wants to import masks(medical mask, kn95, disposable non-medical masks), we prepare a form comparing the main testing items of different types of masks, which will be tested and reported at the mask testing report, you can use this form as a reference to check the reports your supplier send you.

Standards	GB 19083-2010	GB 2626-2006		YY 0469-2011	YY/T 0969-2013
	Medical Protective Mask	Self-suction filtered anti-particulate respirator		Surgical Mask	Single-use Disposable Medical Mask
Standard Scope	A self-absorbing, filtered medical mask for the medical work environment, filtering particles in the air and blocking droplets, blood, body fluids, secretions and other medical protective masks.	Self-absorbing, filtered respiratory protection for the protection of all kinds of particulate matter.		It is suitable for disposable masks worn by clinical staff for procedures such as re-invasive surgery.	Designed to cover the user’s mouth, nose and jaw for use in a general medical setting as a single-use mask to block the exhalation or ejection of contaminants from the mouth and nose.
Bacterial Filtration Efficiency (BFE)	–	–		≥ 95%	≥ 95%
Particle Filtration Efficiency (PFE)	Particle size: The aerosol particle size distribution is 0.075 μm ± 0.020 μm more than the median diameter, with a geometric standard deviation of no more than 1.86 (equivalent to 0.24 μm ± 0.06 μm of the median diameter of the aerodynamic mass, which is simply 0.3 μm diameter particles in air).				–
	Gas flow rate: 85L/min			Gas flow rate: (30 ± 2) L/min	–
	Non-oily particle filtration efficiency rating. Level 1 (≥ 95%) Level 2 (≥ 99%) Level 3 (≥ 99.97%)	Non-oily particulate matter (N). KN90 (≥ 90%). KN95 (≥ 95%). KN100 (≥ 99.97%)	Oily particulate matter (P). KP90 (≥ 90%). KP95 (≥ 95%). KP100 (≥ 99.97%)	Non-oily particle filtration efficiency. ≥ 30%	–
Synthetic blood penetration	Spray 2 ml of synthetic blood at 10.7 kPa (80 mmHg) into the mask with no penetration in the mask.	–	–	Spray 2 ml of synthetic blood at 10.7 kPa (120 mmHg) into the mask with no penetration in the mask.	–
Leakage Performance IL	–	Disposable mask total leakage rate (TIL), replaceable half mask IL, full mask IL with individual requirements		–	–
Compatibility	Total fit factor not less than 100	Negative pressure drop of no more than 100 Pa in each full hood within 60s		–	–
Appearance and Structure	Cup-shaped Bands			Flat-type Earloops

Want to know more details of these 5 China mask standards, download pdf from here.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         But, Does it say in the mask test report that passing the test means the quality of the mask is OK?

Qualified in mask testing report does not mean the masks you get are qualified 100%.

The only thing you can get from the testing report is that: the samples the manufacturer sent to the testing labs are qualified, and the truth is that most manufacturers are not willing to spend extra money to test each batch of the masks they produced and get the related testing report, and this is also no need to do so, let’s explain why.

You might have already known that the most important raw material of an anti-virus mask, is called melt-blown pp non-woven, so, if the manufacturer has a steady supplier of the melt-blown non-woven in his supply chain, and the melt-blown supplier does have test reports of the melt-blown fabric they produce, then there is no need to test each batch of the masks produced, but if melt-blown fabric supplier does change as the production goes, it’s better to test the masks produced with the new raw material from the new supplier.

 

What can a supplier do better to ensure the quality of their masks?

The solution is: third party testing labs report + do the testing themselves.

Like us, TESTEX, even though we only produce disposable face masks and N95 alternative KN95 masks (non-medical), to ensure the quality, we came up with this solution, Thanks to our self-developed mask testing equipment, we can perform quality testing on each batch of our own masks according to the standard requirements of disposable medical masks YY/T 0969-2013 (because our factory is not qualified to produce medical masks, so our masks meet this quality standard, but in order to pass the Chinese customs smoothly, our packaging and declaration on the mask implementation standard are written GB/T 32610-2016), and labeled with the test pass. Together with reports from third-party testing, we ensure to the greatest extent possible that the quality of our masks is qualified.

TESTEX Textile Testing Lab

Testing the mask raw materials quality before mass production at our textile lab, and do specific mask tests to ensure masks produce are safe to wear. Interested in buying tested qualified masks from us, check this page.

Conclusion:

Testing reports is an overrated aspect of indicating the masks you purchase are qualified, its most important function is acting as one of the essential document to pass the custom, and comparing to test reports, find a trusted company to cooperate is much more important, if you are interested in ways to verifying whether a company or manufacturer is reliable, please read this article, help you find this useful.