How not to get scammed sourcing PPE

A step-by-step process on how to verify FDA registrations when sourcing Personal Protective Equipment

I’m exhausted. I’m staring into the bottom of what was my fourth cup of coffee. After a long late-night WeChat volley of messages to prospective Chinese suppliers for face shields needed urgently in New York, I inspect each one of the 5 factory spec sheets and FDA certifications I worked so hard find. Fake, fake, misclassified, pending registration, pending registration. Shit, back to square one. I remember two months back when I nearly paid an agent I have never met $40,000 to stand in front of a factory with cash in a briefcase to get in line for the highly sought after N95 masks, only to find out that it was all a hoax.

I am 9 weeks into my sourcing mission for getting PPE into the US to frontline medical workers and essential staff. It’s been a nightmare. My 12 years of sourcing and manufacturing experience for my LED lighting company in Asia and Latin America haven’t quite prepared me for this.

Many people have entered the PPE space as distributors in the last couple of months for a variety of reasons ranging from admirable to despicable. Hospital and state procurement teams, who normally call their pre-vetted and long time distributor when they need a stock of supplies, are suddenly needing to find new sources. I sometimes question why the head of the procurement department for the State of ****** is contacting me, an LED lighting nerd on the west coast, begging to buy anything I have, and just taking my word that it’s good enough quality to place onto a nurse’s face in the ICU.

I’ve developed a checklist for those sourcing masks and other PPE to decrease the chance of being scammed. When I mention scammed, I mean purchasing counterfeit products, unverifiable quality, or mislabeled products that can get you in major legal trouble. This is not an all-inclusive list, nor am I an expert in compliance. I am sharing what I have learned thus far.

Here’s a helpful guide for how you can determine if the manufacturer of your PPE holds a current FDA registration for the products you intend to purchase, and some other tips not to get scammed.

1. Seller refuses to tell you the manufacturer’s name (RED-FLAG).

In the LED industry, we guard the names of the factories we use when we white-label products so customers or competitors do not try and go direct and cut us out. I have noticed that many PPE brokers are reluctant to provide any manufacturer’s information. However, without this information, you cannot do your job in verifying that the products you are trying to purchase are indeed real and correctly classified. When someone gives me an FDA certificate with the names redacted, I reply, “First week on the job, huh? We are in the middle of a pandemic. If you cannot share that information I am moving on”.

2. The FDA does not issue certificates.

These certificates you see below are not provided by the FDA. They are created by suppliers to easily communicate to their customers that they have an FDA submission and registration number. Do not solely rely on these certificates, but use them as a starting point to get the Manufacturer’s name for the next steps. Many manufacturers use these certificates but there is no registration with the FDA, or the registration has just been submitted and it is pending acceptance

Examples of certificates generated by the factory, not the FDA

3. If N95, is it on the NIOSH list from the CDC? If sourcing KN95 masks: Is the manufacturer on the approved list of Chinese suppliers, per the EUA?

If you are sourcing an N95 respirator, first check to see if the manufacturer and the product number is on The National Institute for Occupational Safety and Health (NIOSH) website of approved respirators. Be careful if you are being sold a mask claims it comes from a manufacturer on the list, but a product/model number that is different from the NIOSH website. It may not have been evaluated by the CDC.

Also, the FDA recently issued another Emergency Use Authorization to help purchasers of PPE understand what is specifically approved to source from Chinese suppliers. To combat so many counterfeits, they created a list of the KN95 Respirators that are Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China.

Do you see your manufacturer’s name on the list? We only work with suppliers that are on this list, but even then, additional steps are needed to make sure what you order from them is what you receive like 3rd party testing from a US-based laboratory.

4. Beware of misclassified goods and understand how the PPE is being imported.

If you are purchasing KN95 or N95 respirators from outside of the country, you need to ask which HHS code is being used to import.

Is this being imported as a Medical Device or a Non-Medical General Use item? If it is imported as a non-medical use item, the seller should be not be selling the items to any buyer for medical use. The importation of counterfeit masks from China can mislead a hospital into improper use, and subject you to liability. For that reason, it is important to follow these steps.

5. Review the FDA Database for Registrations and Device Listing

If the PPE you need to source must be cleared by the FDA, you need to review the manufacturer’s FDA listing on the FDA Database for Registrations and Device Listing. If you are given an FDA certificate shown above from the factory or distributor, you need to also look up the company in this portal to verify it exists. Step by step on how to do this below.

6. Request product test reports

All claims from manufacturers must be verified prior to purchase such as bacterial, viral, or particle filtration. (ASTM II certification, CE certification test report, BFE, PFE tests). If they cannot provide test reports, you must doubt the accuracy of their claims until proven.

7. Ask for photos of the product, the packaging, and shipping boxes.

All most be labeled accurately and not make any false claims or claims that cannot be verified. You must be able to see exactly the product, its presentation, and packaging before you sell it or buy it.

Follow the below instructions.

We have three examples of factories I have tried to source from. One is a fake, one suspicious, and one factory that passed onto the next stage.

FAKE FACTORY EXAMPLE

Go to the FDA listing on the FDA Database for Registrations and Device Listing. Enter the manufacturer’s name under Establishment or Trade Name and search. You can also search for several additional search parameters, including registration number, owner/operator number, or product code. All medical devices registered with the FDA are assigned a three-letter product code. Example: Last week I received an FDA Registration certificate of KN95 masks from Dongguan Medical Yiwu Fashion Products. Look it up in the registry. The name does not appear, no search term matched there for that manufacturer. The seller also cannot provide test reports, photos, or any other evidence of the goods. Fake. Since this is the third fake certificate from this particular sourcing agent, it was time to part ways.

PENDING REGISTRATION (NOT ACTIVE) EXAMPLE

Company contacts me and says they have 500,000 KN95’s in stock “FDA and CE approved”. I look up Dongguan Leihou medical device Co. They appear under the FDA’s search. Have you found a winner? Maybe, but…. be careful.

2. No registration number = pending registration

You will notice that the registration number column says “no number listed”. The registration process can take several months. Most likely a business with “no number listed” has not completed the FDA certification process. The business could have only just recently applied or it could be moments away from getting a registration number. You will not be able to tell from this search alone.

Again this is a PENDING registration! This is not a confirmation of the clearance/approval of their registration!

The FDA has a TWO step process where any company can register their product with the FDA before getting clearance or approval. This registration certificate is given to a company that paid the FDA fee to get registered.

Most of the certificates I receive are just like this one. I would not recommend buying from these manufacturers unless they are on the approved EUA from the FDA’s list. Selling this item as an FDA Cleared Product is inaccurate.

3. Misclassification of code and product description

Under the product description, the KN95 masks are filed under the term scavenging mask. A scavenging mask is worn around the nose to induce inhalation of anesthesia. Be aware of these inconsistencies when sourcing products.

Scavenging mask KHA product code

SIDE NOTE: Please do your research on product codes: Common product codes for PPE are MSH (N95 grade respirators), LYU (surgical apparel, including face shields, gloves), and FXX (surgical mask — non-respirator). Use well-known examples of brands you use and trust to look up in the FDA database and learn which codes are used.

(RED-FLAG) If the manufacturer is claiming the respirator “Filters bacteria, and viruses and COVID-19” but does NOT have an MSH code attached to their profile, but an LYU code, they are making Class II claims under a Class I listing, so be careful of this. Read what the difference is between Class I, Class II and Class III is here.

A WINNING EXAMPLE

I was looking to source non-surgical isolation gowns and was passed an FDA certificate from Xiantao Sanda Industrial Co. LTD.

The factory appeared under the search — check The factory has a registration number, showing an active and approved registration with the FDA — check The product codes are aligned to where they should be and descriptions accurate — check I can move on to the next step of my due diligence (I am far from done)!

NOTE: I did not purchase from this manufacturer and cannot recommend them, as I have not done business with them.

More information about the FDA process:

Clicking on that owner/operator number will bring up a listing of all products for which they have sought FDA registration. It does not mean all of those items have been fully vetted by the FDA.

When purchasing a Class II device you will want to look for a 510(k) report, if it is available. Recent EUA’s have relaxed some of the 510(k) report requirements, so in some circumstances, an item may be available for use as a medical device without first getting this premarket clearance of a 510(k) report. In that circumstance, you should ask for and review testing criteria to ensure the item meets the specifications you require.

If you have a 510(k) report number you can also search for information on the FDA here.

Product labeling

I can write another article about this, but to keep it short you need to make sure that the product is labeled accurately. For N95 respirators, specific labeling is required. Here is an article the CDC wrote about how you can spot a fake NIOSH N95 respirator.

Let’s say you are purchasing general use face mask for your security staff in the hospital’s parking lot. You begin to follow these steps before you purchase. The product shows up on the FDA’s website as a pending registration, filed under a Class I product code LYU (that does not require a 510(K) report), but the packaging says, “used to filter bacteria, viruses, and COVID-19 with >95% blocking of bacteria”. From a compliance standpoint, I would not recommend its use or purchase. The packaging is making Class II respirator claims, but there is not active registration, no test report, and no validation of the claims made on the packaging. Keep this in mind.

Next Steps after FDA registration verification

Before you send that wire for 500,000 N95s in a random warehouse you haven't laid eyes on yet, you may want to:

Review third party test reports if needed Ask for an inspection of the goods before funds are settled Use an escrow service or Letter of Credit Write a sales contract and have it reviewed by a lawyer Collect a copy of the identification of the seller if it is private or the W9 if it is a private company Request samples to inspect before purchasing the lot Is their price fair? Costs are rising weekly due to increased materials costs, shipping costs, and low supply available. I have material costs increase 2X in the last month on the supply side. However, is the seller making 10–20% on these items …or 150–300%? Work with vendors who are honest and not price gouging. Report the extreme cases. Understand that shipping has become more complicated, delayed, and expensive. Manage your expectations for delivery for your employer or customer.

Other questions for your supplier:

Off the top of my head, here are some other questions I have when verifying a supplier or distributor.

Do they have a medical import license if they are arranging the shipping from overseas? How are they importing the items and under what HHS code? If sourcing N95 alternatives, can they source PPE from the approved factories on the FDA’s EUA list? Are their items currently in the USA or abroad? Who takes the shipping risk? I recommend putting that on the distributor. Have you received their W9 and vetted their company? Does their banking information match the W9? Does this company have experience in manufacturing, distribution, supply chain management, or sourcing? Have you spoken to their trade references? Have they completed third party testing in the USA verifying the manufacturer’s claims or claims on the item’s packaging? How can they prove they have the inventory they are claiming they have (or they can get)? Do they have photos of the items that they can verify are in front of them? I have been in many situations where a broker was selling a broker’s broker’s broker’s supplier’s inventory. Be careful and try to verify as seen below.

Final words

This is not an all-inclusive list but will provide you some guidance into how to take some appropriate steps to verify a seller’s claims while sourcing PPE.

When you hear about a State Government wasting $10,000,000 on poor quality KN95s, fake test kits, and counterfeit 3M products, it is most likely because they are purchasing from distributors that are not following the correct steps to verify the products they are selling, or the state’s purchasers themselves are not experienced in sourcing from non-traditional sources when supply chains are disrupting.

For those in the fight, keep fighting. The correct procedures to source PPE must be followed, as lives are at stake. This may slow down your efforts to provide PPE as soon as possible, however, we have a responsibility to take all necessary steps to protect those who we are selling to. Remember, slow is smooth and smooth is fast.

About us: We started Thermba to assist in providing our frontline medical staff and essential workers quality PPE, as traditional supply chains have been destroyed. We purchase and stock materials in the USA from three manufacturers that are on the Emergency Use Authorization Appendix A. I am committed to educating those around me and helping procurement departments to make smart sourcing choices. Please comment below with questions or changes needed to this article.