What’s The Real Deal With The Masks?

 
Dear ActionPPE supporters,
In response to the inquiries generated by media reports I hope this memo helps clear things up - we are as concerned about safety (I am wearing the PPE as I write this) as you are.  
Let me address the most common questions and concerns I hear from Doctors and Staff regarding the KN95 masks.

 Q: I am concerned about the quality of the KN95s; how do we know they are not fake? ; I can’t find the manufacturer listed on the WSJ list; My mask has ear loops! Some masks were faulty – is that because they’re fake?  Since they’re cheaper are they not as good?  Why can’t we get N95s?
A: Nearly half of masks produced globally are produced in China. Unfortunately, many N95 and KN95 are fake and do not meet NIOSH or CE specifications. This has rightfully caused a huge concern among health professionals.
The KN95 masks provided via ActionPPE are manufactured by Anhui Moke Medical Technology Co., Ltd. in Anhui province, China under the brand name MOKE KN95.
The FDA set a directive on April 3rd, 2020 allowing for the use of KN95 masks from China https://www.nytimes.com/2020/04/03/health/coronavirus-n95-kn95-masks.html . The KN95 standard is functionally equivalent to the US NIOSH N95 in filtration efficiency as per this 3M technical bulletin comparing N95, KN95, and FFP2 masks: https://multimedia.3m.com/mws/media/1791500O/comparison-ffp2-kn95-n95-filtering-facepiece-respirator-classes-tb.pdf
In addition, ActionPPE has done the following due diligence on the MOKE factory and KN95 product:
  1. ActionPPE works ONLY with vetted suppliers who have staff on the ground in China to inspect factories in-person. The supplier’s local Chinese staff have done an on-site inspection of the Moke factory in Anhui, met with Moke factory managers, inspected the masks and reviewed the test results and certifications.
  2. We require valid US FDA/NIOSH, EU CE, and/or China FDA certifications. Moke has a valid KN95 EU CE product certification. Go to this EU CE site: http://certificate.entecerma.it/en/CertificateVerification.aspx#  and search this Certificate Number: 5C200413.AMMTQ95. In addition, the official test report from the 3rd party lab is available in the updated Moke product spec sheet. It shows a filtration efficiency of the 15 sample masks to have a FE% of 98.6% to 99.7%, exceeding the NIOSH N95 95.0% specification. See the MOKE Specification sheet for additional details.
  3. Each shipment is inspected by the supplier’s staff BEFORE it leaves China.
  4. Suppliers to ActionPPE are required to be a US company with a validated IRS Tax ID number (EIN).
  5. Additionally, ActionPPE is making arrangements for testing with Nelson Labs (Salt Lake City, UT) https://www.nelsonlabs.com/facemasks/. Our supplier also is a distributor to the Swiss postal service SwissPost https://www.post.ch/en who also sends the masks to an independent lab in Switzerland for compliance testing.
Q: What about the ‘ear loops’ vs. ‘behind the head straps’?
A: It is a design choice made in China for comfort.  The company feels that this style fits the KN95 better which is made of softer materials than the ‘form-stamped’ N95s.  We have asked if elastics can be supplanted and we have yet to hear.  Bottom line –the MOKE KN95 masks are made with ear loops.

Q: An earloop broke on one of my masks. Is this normal? What should I do?
A: –It is not normal and we will replace it. Though each one of us expects a perfect package the reality is that in over 500k units there are bound to be some spoiled units.  Let us know and we will replace those immediately.  Our supplier has spoken with the factory about this issue. The factory said they have had very few quality issues in the millions of masks they produce monthly but are sending us replacement masks. We won’t let one rotten apple ruin the whole bunch.

Q: Why can’t we just get N95s?
A: We can, if we order a couple of million, pay extortion prices and have a Dreamlifter to pick them up.  The reality is that the artificial demand has created a distorted market for these.  You are more likely to buy a fake N95 than KN95, FEMA is more likely to seize giant shipments – just look at the news.  Finally, the largest manufacturers of N95s have decided to not do business with the US (geopolitics and trade wars) and service the rest of the world.  So, the list of ‘FDA approved’ suppliers has gone down to less than 16 which will only make the availability, incentive for forgery, etc. even worse.  Of course, the hospital systems and agencies can afford to play this game.  We are better off with what we can reliably get.
That is why we have partnered with a company that has 20 years’ experience with China and has an established supply chain – they are not a ‘last minute trader’, ‘charter flight operation’, or ‘new PPE provider’ that have exaggerated the demand for N95 masks specifically (and are rapidly going out of business).

I was on the phone last night with our Distributor in the US (across the street from my alma mater in Palo Alto, CA) and his partner in China.  Both have lived in China, are fluent in Chinese and the business culture there.  It has been enlightening to hear the ‘behind the scenes’ info on the PPE factories and suppliers.
We have done as much due diligence and to the best of our ability that we can.
Marcelo Hochman MD
President
Charleston County Medical Society