FAQ

I have heard there were lots of issues regarding exporting and importing of masks from China, what are the issues we should look out for?

Chinese export regulations for PPE have changed many times since the beginning of the year, you need to check factory’s certificate and product test report, check product packaging and labels, make sure this product complies with both export and import country’s policy.  You need to prepare full set of documentation for customs declaration.  Find people… Continue reading I have heard there were lots of issues regarding exporting and importing of masks from China, what are the issues we should look out for?

FAQ

The prices are all over the place, what is the fair price to pay?

The price is very high now, even though it is part of the supply-demand equation. The best you can do in this environment is to get a fair price.  You have to deal with the manufacturer or the manufacturer’s authorized US agent, please avoid Chinese “bidding platforms”—most stuff there are fake. At the end of… Continue reading The prices are all over the place, what is the fair price to pay?

FAQ

Are there counterfeit/fake/scam, and how do we avoid them?

Booming demands spawned many new manufacturers for masks, and in the market there are many different brands and fake goods.  CDC lists some examples, but they are far from exclusive: https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html   There is no simple way to avoid bad and get good.  Dr. Astro is a team with decades of experience in China medical… Continue reading Are there counterfeit/fake/scam, and how do we avoid them?

FAQ · N95

We need masks for our doctors and nurses, are KN95 good to use?

NO. See FAQ “#1 difference between N95 and KN95?” Furthermore, Chinese government issued its own regulation prohibiting masks such as KN95 from exporting for medical use: on 2020/4/1 three Chinese government Ministries, General Administration of Customs, the Ministry of Commerce, and MNPA (the Chinese FDA), jointly announced the new regulation that prohibits export of Masks… Continue reading We need masks for our doctors and nurses, are KN95 good to use?

FAQ · N95

How do these masks compare with the mask we are used to?

They may look and feel different—most of the CN95 have ear loop rather than headband.  Chinese regulation does not require the headband, and since ear loop is easy to put on and take off, and it feel better, it is more widely used.  Selected manufacturers are in the process of applying US NIOSH, and they… Continue reading How do these masks compare with the mask we are used to?

FAQ · N95

Since we can’t get the mask we are used to, what are the alternatives?

NMPA (Chinese equivalent of FDA) has strict regulations and standard for Medical Protective Mask.  The best alternatives are the Chinese N95: CN95.  Chinese N95 has the standard called GB 19083, which technically is equivalent to NIOSH standard. But the most important is the certification agent: the Chinese equivalent of FDA (National Medical Products Administration; NMPA).… Continue reading Since we can’t get the mask we are used to, what are the alternatives?

FAQ · N95

Why can’t we get the mask we are getting last year?

The masks we used to use are N95 masks quality tested by NIOSH and registered and regulated by FDA, usually under the product code MSH with 510K if the masks were used to prevent virus transmission. 

 

Due to Covid-19 epidemic, N95 mask usage increased >100X, so in a month, we used up ~10 year’s stock/production.

 

The allowance of NIOSH approved industrial masks in medical settings alleviated the situation by ~2x, and manufacturer’s ramped up production by ~2x.  Not Enough! We still used up 2 years of production capacity in a month!  To only rely on the masks we used to get, the waiting line is going to be years.  A source says that we only have 1% available for 1 year of supply.  Either way, we need alternative sources.

 

That’s when China comes in—China’s got volume but the difficulty there is how to ensure the quality we need.

 

These links have more details on the topic:

 

Factories are scrambling to make 20 times more face masks a day to keep up with demand amid coronavirus outbreak, but the masks are surprisingly difficult and expensive to make.

https://www.businessinsider.com/why-factories-cant-keep-up-demand-for-face-masks-coronavirus-2020-4#before-the-pandemic-half-the-worlds-face-masks-were-made-in-china-and-most-us-companies-that-have-converted-the-factories-to-make-n95-face-masks-get-their-melt-blown-fabric-from-china-16

 

What’s behind the N95 mask shortage?

https://www.mprnews.org/story/2020/03/30/faq-whats-behind-the-n95-mask-shortage