N95 Respirators - Can we label our masks as N95?

Lokus200

Starting to get Involved
#1
Hi all,

I hope I am posting it in the right place. I have a question hope you can help me with: what exactly is N95? Is that a standard belong to NIOSH or is it a filtration rate?
If someone wants to claim N95 on the label, does it mean it must be tested and certified by NIOSH or it can be tested in any other testing lab?
If someone has an N95 claim on the label but tells me it was tested by an independent lab (not NIOSH) and test result complies with N95 requirement is that ok or it will be considered misleading information?

Thanks for your help.
 
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chris1price

Trusted Information Resource
#2
FDA have a page specifically on the subject, I would start here

N95 Respirators and Surgical Masks (Face Masks)
https://www.fda.gov/media/136449/download

"The 'N95' designation means that when subjected to careful testing, the respirator blocks at least 95 percent of very small (0.3 micron) test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks. However, even a properly fitted N95 respirator does not completely eliminate the risk of illness or death."


Or look at CDC
CDC - NIOSH-Approved N95 Particulate Filtering Facepiece Respirators - 3M Suppliers List
 

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Watchcat

Trusted Information Resource
#3
You might also find these helpful. One is from 3M, a comparison of masks meeting different international standards. The other is just some information posted by some guy on the internet, but he seemed very knowledgeable and not politically besotted. I found it through, interesting and enlightening, but decide for yourself.
 

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Lokus200

Starting to get Involved
#4
Thank you all, however it does not answer my question. My colleague has respirators tested to FFP2 (Europe EN 149-2001) and KN95 (China GB2626-2006) , he wants to put an N95 label on them, can he do it? is it legal? So far no external consultants were able to provide answers.
The question is not about the standards, I understand they equivalent. The question is about the legality of claims, I was told that I can label the product as N95 only if tested by NIOSH, is that correct? Does anyone know?

Thanks,
Alex.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
Since your question is really "Can we label our masks as N95?" I have updated the discussion thread title.
 

Watchcat

Trusted Information Resource
#6
I was told that I can label the product as N95 only if tested by NIOSH, is that correct? Does anyone know?
If you are talking about labeling it for sale in the US:
CFR - Code of Federal Regulations Title 21

I found some of the language confusing on a quick read, but I don't need to know, so I'll leave it to you to read through carefully and then come back and ask if anyone can clarify anything that seems confusing to you.

I am aware of two product codes under this regulation, FXX and MSH, but you might want to see if there are others that might be a better fit for your mask.
 

monoj mon

Quite Involved in Discussions
#8
Thank you, they are not selling in US. The manufacturer wants to brand his product as N95, the question can he do that?
Since the question is "You CAN or CAN NOT brand the mask as N95", then I would say it depends on the country you are selling it. I don't have any experience working with the surgical masks or respirators, but I found some information on the internet and I think it may help you a little bit!

To brand as N95, I assume it has to be NIOSH approved, see this statement for example if you are selling the respirator in the US. Otherwise, if you are selling it in the EU region then, I think the standard is different. Also, follow this article for a greater comparison of the standards varying by country. So, in summary, I think, to brand as N95 the respirators should be approved by NIOSH, isn't it!

On a side note, if you believe (and have the evidence based on testing conducted following any relevant standard) that your respirators have the filtration capacity equivalent or superior to the N95 requirement then you could also consider to put a disclaimer like what Medtronic has done with one of their device following the recommendation from SAGES.
 

monoj mon

Quite Involved in Discussions
#9
The other is just some information posted by some guy on the internet, but he seemed very knowledgeable and not politically besotted.
On a different note than the original question, thank you Watchcat for the information. The document that you provided, at page 2 the author has said,
"2. Are people who wear surgical masks less likely to get infected during epidemics?
It’s unethical to randomize people to wear vs. not-wear masks during a pandemic, so nobody has done this. Instead we have case-control studies. After the pandemic is over, scientists look at the health care workers who did vs. didn’t get infected, and see whether the infected people were less likely to wear masks. If so, that suggests maybe the masks helped."

Well, actually last month I saw a study from "Denmark" contradicting the above paragraph, where participants are randomized to "wear" vs "not-wear" masks when coming out of home. Anyway, this article was published prior to the study from Denmark, so definitely the author was not aware of it.
 
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