AVOIDING COUNTERFEITS & SCAMS

Over 35 years of sourcing various goods from China, we decided in March 2020 to officially take a stand and incorporate a new business entity specific to helping healthcare providers get what they need.


The influx of fake masks coming into the market is astounding and we have already seen waves of regulation. Governments are trying ways to counter these fraudulent vendors, but here's how you can know for yourself whether mask is real or fake.

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VERIFY A NIOSH CERTIFICATION

NIOSH is part of the CDC within the US Dept. of Health and Human Services. This site will tell you which N95 respirators are NIOSH and/or NIOSH + FDA cleared. However, it will not list N95 respirators that are only FDA cleared.

You will need the legal name of the manufacturer, the N95 model number, and the TC / 84A-xxxx number.

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VERIFY 510K PREMARKET NOTIFICATION CLEARANCE

Ask the manufacturer for the product's 510K letter issued from the FDA. That letter is the premarket notification clearance letter. In that document is a reference number that starts with the letter "K". That is the 510K Number issued by the FDA when the product has cleared the premarket notification process and meets FDA standards. Use that number to verify their status online.

Note: The Product Code for N95 surgical masks is "MSH"

VALIDATING CE CERTIFICATIONS

CE certifications are a little trickier to validate. You will request the CE certification from the manufacturer. Then you'll contact the 3rd party certifying authority who issued the certification, who's information should be on the certificate. Many certifying authorities have sites that allow the user to lookup a certification. CE certification numbers start with the letters "EN".

Check out the European Safety Federation (ESF) site for examples and various ways to spot a fake certificate.

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ARE KN95 MASKS OK?

Depends. Some are substandard. But if you can find a US based company with factories in China, then you'll get a KN95 that is equivalent to its US model.

 

For Example, our KN95 Honeywell H801 model is equivalent to the N95 H801 Honeywell. Same Company. Same mask.

The FDA has connected directly Chinese manufacturers in China too. Here is the official FDA list of authorized Chinese manufacturers.

FDA AUTHORIZES NIOSH APPROVED RESPIRATORS IN HEALTHCARE SETTINGS

FDA Authorizes the use of all disposable FFRs (Filtering Facepiece Respirators) approved by NIOSH in a healthcare setting. These FFRs do not need FDA approval or 510k clearance during COVID-19 crisis.

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EUA Letter

EMERGENCY USE AUTHORIZATION (EUA)

The EUA permits the emergency use and distribution of filtering facepiece respirators (“FFR”), certified by the National Institute of Occupational Safety and Health (“NIOSH”),1 that had previously been intended for general use.

IMPORTED, NON-NIOSH-APPROVED DISPOSABLE FILTERING FACEPIECE RESPIRATORS ALLOWED

On March 28th, The FDA allowed certain respirators / masks to be allowed in healthcare settings during the COVID-19 crisis.

See Section II in the Official re-issuance letter from the FDA.

NON NIOSH NON FDA ALLOWED

Now that you know our process, see what's available.

WHAT TO ASK FROM A POTENTIAL SUPPLIER / DISTRIBUTOR

Chances are you're getting bombarded with suppliers offering their services. What do you do with all of them? The old vendor form process takes time. Consider creating an emergency expedited process like the FDA's expedited process called the EUA (Emergency Use Authorization). 


At a minimum, ask each potential vendor for the below 6 items, then use the links above to vet them. Then call them.

To expedite the process you can call the vendor for their certification numbers so you can the start vetting process as vendors gather the below information for submission.

Examples of Legitimate Certification Numbers:

FDA 510K No.: Starts with "K" (e.g. K020102)

NIOSH Ref No.: TC-84A-1234

CE Certification No.: EN 123-4567

Items to Ask from a Potential Vendor:

1. Certifications of quality (NIOSH, FDA, CE, etc. as applicable)

2. Samples

3. Pricing

4. Business License

5. Website URL

6. Photos

CERTIFICATIONS - HOW TO VERIFY

The Food and Drug Administration (FDA) has expanded their scope of allowable face masks to be used in healthcare settings. The ideal mask would be an N95 surgical mask which means it's cleared by the FDA and is NIOSH approved, but those are a rarity and cost a premium price.

When a vendor provides their manufacturer's information, lookup the manufacturer's information on CDC.gov and FDA.gov website with their provided reference number.

Use the 510K Number (starts with a "K") on the FDA site.

At CDC.gov, the manufacturing companies listed alphabetically.

SAMPLES & SHIPPING TERMS TO REDUCE RISK

You always need to ask for samples. Photos can be taken from any website. However you also need to be aware that larger shipments may differ from the samples provided. If you are a reputable or well known company, then suggest paying COD or "cash on delivery". The issue with COD during the COVID-19 crisis is that demands are extremely high.


COD shipping terms ties up a supplier's cash until paid. While it being a preferable term for buyers, many suppliers do not have enough liquid cash to accommodate every customer, especially with large orders.

Alternative options may include smaller orders until you're comfortable with the supplier and the shipping process, or 50% upfront, 50% on delivery, depending on company's cash on hand.

WHY IS THERE SO MUCH FRAUD?

Good question. Short answer: High demand + scarcity + fear = frantic buyers. 

Who's to blame? 

We have seen hundreds of new businesses in China pop up without proper certifications. They sell to fill a need with a "something is better than nothing" mentality, however, ethics becomes violated when there is an attempt to deceive.

The best way to stay clear from fake PPE in China is to only purchase FDA authorized or CDC approved materials. However, the best way to stay clear from fake PPE and find supply is to find the hidden gems. How? US based companies that have factories abroad. This means quality at a reduced price. The probability to clear customs is best since it's a major US brand coming into the USA. Because they are US companies in other countries, don't expect the packaging to be in english or have the same labeling such as NIOSH since US regulations don't apply to consumers in other countries. In short, if you're purchasing masks, you can get a N95 NIOSH quality from Honeywell or 3M at a reduced price.

IS COVID-19 ALMOST OVER?

According to various news sources, the USA should be seeing the peak for COVID-19 new cases from April 6th to 20th. This does not mean the coronavirus will be gone, it simply means we are starting to slide down the other side of the bell curve. New cases will still be found and if we are not careful, new cases could increase again.

Many government agencies and branches are working remotely through June of this year.

US based factories are trying to double their production even now and for the next 12 months due to the continued deficit of product in our country.

UPDATE: June 2020

The US economy is starting re-open as individual states allow businesses to re-open in a phased approach. Some states require the use of masks in public. Please check your state's guidelines for more information.

COVID will most likely be a topic in the news up through the presidential elections in November. While we suspect a resurgence of cases as the businesses return to normal operations, this is to be expected when individuals emerge from isolation. Check out our blog post regarding this.

DO NON-NIOSH APPROVED RESPIRATORS PROTECT FROM COVID-19?

As mentioned in CDC's strategies for optimizing respirator supply, other countries approve respirators according to standards. These devices are evaluated using methods similar to those used by NIOSH, and are still expected to provide adequate protection for healthcare personnel, given shortages of FFRs resulting from the COVID-19 pandemic. Under these circumstances, FDA believes these devices may serve as suitable alternatives for personal respiratory protection during this period of shortage caused by the COVID-19 pandemic.

 

©2020 by Priority Healthcare Products, Inc.

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