UPDATED: May 1, 2020
N95/KN95 Half Mask Disposable Filtering Facepiece Respirator (FFR)
There is a lot of confusing and misleading information online about N95 and KN95 masks. Unfortunately, many suppliers and brokers are trying to take advantage of the current mask shortage by offering non-approved products at excessively high prices. Some products are being marketed as “Fit For Use by Medical Personnel”, however they are not being compliant with the guidelines established by the Center for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA).
Given this situation, our company has reviewed the CDC and FDA documents and has also communicated directly with their representatives in order to get the full picture.
We have created this FAQ to give you some key information so that you can be knowledgeable and know what questions to ask when procuring Disposable Filtering Facepiece Respirators for yourself or organization.
If there are questions not answered here, reach out to us directly and we will do our best to answer. We will be updating this guide regularly as more information is available from the CDC and FDA. For a complete understanding of their guidelines, we suggest that you visit their respective websites.
What is the difference between a Surgical Mask and N95 Respirator?
These are two very different products and provide different levels of protection! Below is a basic comparison. Please click the following link for more detailed information.
What is a N95 mask?
"N95" is a marketing designation that is used in the United States. Masks that are labeled as N95 have been tested and certified to the NIOSH standard, which was developed in the United States. Health care professionals have been using N95 products for a very long time.
What is a KN95 mask? And are they all the same?
"KN95" is a marketing designation that has been used primarily in China. KN95 certified products are manufactured in China and are supposed to meet the standard GB-2626. While GB-2626 may have similarities to the NIOSH standard, they are not exactly the same.
Chinese KN95 mask manufacturers that sell their products outside of China are required to have their products tested in accordance with the test standards of the region that they want to sell into. For example, in order to sell masks into Europe, the products must also meet the European standard EN-149-2001.
All KN95 masks are not the same. Some may have been tested to comply with the Chinese GB-2626 standard only and not to GB 19083-2010 standards. Other models may have been tested under additional standards (ie - European) to meet the needs of other markets. It's very difficult to know what type of product you have unless you review the testing data and take guidance from the FDA and CDC.
My organization is experiencing a shortage of N95 masks. What alternative types of masks has the FDA and CDC authorized?
Given the current supply issues of N95 masks, the CDC and FDA have evaluated masks from other countries and have provided the following guidance regarding the use of other types of masks.
The CDC and FDA has provided a list of testing standards that are used in other countries which are considered similar to the US based NIOSH standard. This list is shown below with a more detailed description available here. FFR products that meet these standards are expected to provide protection similar to a NIOSH approved product.
As such, the general guidelines during times of NIOSH mask shortages are:
1. An organization should first use an NIOSH approved N95 face filtering respirator whenever possible.
2. If not possible then:
What certifications do the KN95 masks distributed by On The Go Screens (Valera Screens) have? Are they allowed to be used under the guidelines above?
Our masks have been tested and certified to the standards of China. They meet the GB 2626 and GB 19083-2010 standards. While we wait for final FDA approval, our products are approved for consumer use with medical grade standards.
Are your masks currently being used in the United States?
Yes, please see the videos where our masks are being distributed in New Hampshire.
Can you send me the manufacturer information and test data?
Yes, please fill out the Inquiry Form and we will email you the reports along with any other information we can provide.
I am a health care organization or distributor. Can I purchase masks from you?
Yes, please fill out the Inquiry Form and we will follow up with you promptly with pricing information.
I am a consumer. Where can I find your products?
You can visit our online store to purchase our products. We are currently working with our partner Amazon.com to get our products setup for sale to consumers. If you would like to be notified when we are online with them, please let us know via the Inquiry Form.
I have other questions that haven't been answered here. What do I do?
Please contact us via the Inquiry Form and let us know your questions. We will do the best we can to provide you with the information you need.
We are currently in a very dynamic situation where information and guidance from the FDA and CDC is evolving. We are in touch with these organizations and doing what we can to share the latest information with you as accurately as possible. As we are not official representatives for these organizations, we encourage you to also visit their websites. www.fda.gov, www.cdc.gov