PPE Information

How to Verify Them, An Explanation of the Various Certifications

To help everyone better understand the various certification requirements and what each one means, we have assembled the following short guide.

You will encounter the following terms referring to items being certified or approved when dealing with buyers and sellers of PPE and other medical equipment during the COVID-19 pandemic. (NIOSH, FDA Approval, FDA registration, CE mark or CE approved, EUA.)

NIOSH Approval

(NIOSH approval is currently required for N95 Respirators)

NIOSH List – CDC – NIOSH-Approved N95 Particulate Filtering Facepiece Respirators

How to use this list: Search for the manufacturer name first in the first column (for example Shanghai Dasheng Health Products Manufacture Company, Ltd.), then look for the model number in the second column (for example DTC3x). If the model number is on the list it is NIOSH approved (the NIOSH approval number is the third column). If the approval number is bold, then the mask is both NIOSH and FDA approved.

The FDA has recently approved several non-NIOSH options under the Emergency Use Authorizations. See them here – FFRs Manufactured in China.

FDA Approval

“Approval” generally only applies to “high risk” medical devices (Class III), such as ventilators and other machines, parts, and accessories for these, filtering devices (however NIOSH only has been approved for these), PAPR/CAPR, Pharmaceuticals, and test kits, etc. You can search here – Recently-Approved Devices | FDA

Low-risk items are not generally FDA approved, but generally need to be registered. Items in this group include equipment such as goggles, gowns, booties, face shields, and similar items. You can find out by searching for it in this database. – Product Classification

FDA Registration (not approval) – If a device is a class 1 (low risk) device – a premarket notification application and FDA clearance are not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment as well as the item they intend to manufacture. You can check if a company or device is registered here – Establishment Registration & Device Listing

This is where there is a lot of confusion. An FDA approval and FDA registration certificate is not the same thing, so knowing which one is needed where is important! An FDA registration certificate alone for a respirator, ventilator or pharmaceuticals is not ok, but it is for standard class 1 PPE gear. A respirator would be a NIOSH approval number, a ventilator or test kit (class III devices) would require an FDA approval, and basic PPE would require an FDA company/product registration. If a manufacturer is registered as a company, the item type itself must still be registered under their device listings under that company’s name.

Emergency Use Authorizations (EUA’s)

These are the items that have fast-tracked approval for the duration of the crisis. – Emergency Use Authorizations | FDA for a particular category, look for the “appendix” links if you don’t see the device listed in the main category. (You can find currently approved COVID-19 tests here)

CE Mark of the European Union

The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985

This mark may well be acceptable for some products, but understanding where the Chinese export economy can be deceptive here is important. In China, where factories pump out substandard imitation goods all too commonly, companies often supply products meant for foreign sale with unsubstantiated “Chinese Export” labels that can look like this:

Here is a comparison of the actual European CE mark with the most common Chinese export mark:

Databases You Can Search