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ASTM Level 2, FDA 510(k) Surgical Masks (50 Pack) $29 + Shipping @ Uline

$29.00
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Uline has a 50 pack of surgical masks for $29 + shipping (approx $15 for me). Max 6 packs per customer and yes they appear to be made in China.

Listed as ASTM Level 2 (98% particulate filtration) and FDA 510(k) reviewed/cleared? as Class 2 devices:

Product (was only able to see this using a desktop browser):
https://www.uline.com/Product/Det...gical-Mask

FDA Registration:
https://www.accessdata.fda.gov/sc...3&lpcd=FXX

FDA 510(k) Pre-Market Notification:
https://www.accessdata.fda.gov/sc...id=K123787

FDA 510(k) Summary, Testing, Review:
https://www.accessdata.fda.gov/cd...123787.pdf

Getting a better seal with surgical masks:
http://www.fixthemask.com
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21 Comments

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This comment has been rated as unhelpful by Slickdeals users
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#2
They have N95 masks too but you need to have preexisting orders.
Not a bad deal but the shipping charge is too much.
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#3
Quote from keylife
:
They have N95 masks too but you need to have preexisting orders.
Not a bad deal but the shipping charge is too much.
Agreed, it seems if you buy multiple boxes the shipping price remains around the same. Might help some.
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#4
Quote from Surly3
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Agreed, it seems if you buy multiple boxes the shipping price remains around the same. Might help some.
It looks like this is tested in 2013-2014 and there is no information on whether this is the tested mask.

Have you seen the following? https://buy.armbrustusa.com/colle...-limit-one

I know they sent masks for ASTM test and no updates since then. Is it possible their masks failed the test?
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#5
Quote from kontrolet
:
It looks like this is tested in 2013-2014 and there is no information on whether this is the tested mask.

Have you seen the following? https://buy.armbrustusa.com/colle...-limit-one

I know they sent masks for ASTM test and no updates since then. Is it possible their masks failed the test?
Yes, I dobut Uline is selling different masks than what was approved however their site has conflicting information sometimes. In this case their site mentions aluminum nose clips but the 510k report tested plastic nose clip masks.

I've looked at Armburst but their shipping is taking forever and their customer service is completely unresponsive to calls, emails, texts. They've apparently tested 35 masks with Nelson labs that all passed the fluid resistance tests but nothing yet on bacterial or particle filtration efficiency. I do trust them though based on their principles, openess, and materials they claim to be using. Others who bought them seem convinced as well but only continued testing and clearances will show. They list on their site that they are now FDA EUA approved. In speaking with the FDA I found out that it probably doesn't take a tremendous amount of validation to get the emergency use approval.
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#6
I placed my order for these on Friday and they were just delivered today, so even while the price isn't great this does seem like a solid option if you need masks ASAP.

Attaching some photos of the masks I got. They came in a ULINE box, with a somewhat generic authenticity paper on the inside. I don't really know what to look for but the masks do feel fairly solid; I cut one mask into half and the nosepiece seems to be white plastic which matches the 510k report data mentioned in the previous post.

Please let me know if there are any other questions.

I have an order open with Armbrust from May (scheduled to ship June 12th originally) with no ETA and no response from their customer support over multiple e-mails. Once those eventually arrive I can try a comparison.
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#7
Why would the general population need level 2 surgical masks?
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#8
Quote from killamajig
:
I placed my order for these on Friday and they were just delivered today, so even while the price isn't great this does seem like a solid option if you need masks ASAP.

Attaching some photos of the masks I got. They came in a ULINE box, with a somewhat generic authenticity paper on the inside. I don't really know what to look for but the masks do feel fairly solid; I cut one mask into half and the nosepiece seems to be white plastic which matches the 510k report data mentioned in the previous post.

Please let me know if there are any other questions.

I have an order open with Armbrust from May (scheduled to ship June 12th originally) with no ETA and no response from their customer support over multiple e-mails. Once those eventually arrive I can try a comparison.
The paper slip says it's YY/T 0969-2013 standard, which is for Single-use Medical Face Mask. Not even surgical mask standard (YY 0469). I don't know why it's listed as ASTM Level 2...
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Last edited by ys115 June 30, 2020 at 12:57 AM.

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#9
Quote from Surly3
:
Yes, I dobut Uline is selling different masks than what was approved however their site has conflicting information sometimes. In this case their site mentions aluminum nose clips but the 510k report tested plastic nose clip masks.

I've looked at Armburst but their shipping is taking forever and their customer service is completely unresponsive to calls, emails, texts. They've apparently tested 35 masks with Nelson labs that all passed the fluid resistance tests but nothing yet on bacterial or particle filtration efficiency. I do trust them though based on their principles, openess, and materials they claim to be using. Others who bought them seem convinced as well but only continued testing and clearances will show. They list on their site that they are now FDA EUA approved. In speaking with the FDA I found out that it probably doesn't take a tremendous amount of validation to get the emergency use approval.
FDA registration seems to be a simple procedure. One of the pictures on their website showed ASTM2100 pending earlier but I can't see it anymore. They removed the picture showing pending ASTM 2100 testing at Nelson and they did not add ASTM2100 to the product specs. I find this questionable.
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#10
Quote from kontrolet
:
FDA registration seems to be a simple procedure. One of the pictures on their website showed ASTM2100 pending earlier but I can't see it anymore. They removed the picture showing pending ASTM 2100 testing at Nelson and they did not add ASTM2100 to the product specs. I find this questionable.
Me too. As much as I am happy to see and support an American company doing this in our homeland I get the feeling the owner keeps marketing everything on American owned/built and not really discussing how effective his product is, not to mention their lack of customer service. There are some YouTube videos where he discusses the plan to reach milestones for ASTM and FDA 510K clearance but it could be months down the road. There is also some incorrect information about the coronavirus in one of his videos. Once they have that I wonder if the price will increase as well but hopefully not. Yes, I noticed the Nelson labs test sheet disappeared and the FDA EUA banner is now there which tells you nothing. I don't even know what's involved in getting that EUA approval and if there is anything on the FDA site we can search vendors who have it and what they did to get it. Perhaps it's just like registering?
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#11
Quote from killamajig
:
I placed my order for these on Friday and they were just delivered today, so even while the price isn't great this does seem like a solid option if you need masks ASAP.

Attaching some photos of the masks I got. They came in a ULINE box, with a somewhat generic authenticity paper on the inside. I don't really know what to look for but the masks do feel fairly solid; I cut one mask into half and the nosepiece seems to be white plastic which matches the 510k report data mentioned in the previous post.

Please let me know if there are any other questions.

I have an order open with Armbrust from May (scheduled to ship June 12th originally) with no ETA and no response from their customer support over multiple e-mails. Once those eventually arrive I can try a comparison.
Thanks for sharing. How is the nose clip? Does it truly shape around your nose and keep its form and not pop up, leaving a good seal?
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#12
Quote from ys115
:
The paper slip says it's YY/T 0969-2013 standard, which is for Single-use Medical Face Mask. Not even surgical mask standard (YY 0469). I don't know why it's listed as ASTM Level 2...
Good catch. I'm not familiar with these standards but this would be a good question for Uline since they are listing it as surgical masks, ASTM Level 2, and the FDA clearance states they should market them as such. Please let us know if you contact Uline about this.
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#13
I bought the Armbrust ones too. I ordered mine June 6th and they arrived on the 25th so I didn't have shipping issues. I haven't tried them yet.
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#14
Quote from ChristianM19
:
Why would the general population need level 2 surgical masks?
They are a cheaper option for a mask that will actually filter out particulates down to 0.1 microns at 98% efficiency. So it will protect others and the theory is that it should protect you from catching the virus to some extent. How effective it is depends on it truly being ASTM Level 1 or higher, a good seal using DIY modifications, trajectory/quantity of the particles, total leakage on the side and top, etc. The material itself is capable of pretty good filtering but wearing it to fit as well as a N95 will determine how effective it is at protecting the one wearing it. If worn normally it will definitely help protect others around you. Some people wear them on top of N95 and other respirators for added protection, exhalation valve covering, and increasing the durability of the N95.

Check out www.fixthemask.com for some ideas. Not sure how well they work though, I am still testing some.
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Last edited by Surly3 June 30, 2020 at 06:56 AM.
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#15
Quote from shamrock
:
I bought the Armbrust ones too. I ordered mine June 6th and they arrived on the 25th so I didn't have shipping issues. I haven't tried them yet.
Let us know how the nose clip is and if it maintains its shape. Thanks.
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