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Costco: FDA Listed Face ≥95% BFE/PFE - 50 for $25.99

$25.99
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APPROVALS AND CERTIFICATIONS
  • FDA approval: product code QKR
  • Health Canada, Class I, PPE
FEATURES:
  • ≥95% BFE (Bacterial Filtration Efficiency)
  • ≥95% PFE (Particle Filtration Efficiency)
  • 3-layer protection with melt-blown middle layer for particle filtration
  • nose clip
  • earl loop
Homedics clearly states [homedics.com] these are compliant with FDA standard QKR [fda.gov] and are Level I in Canada. This means that these masks are appropriate for use in US or Canadian medical facilities/hospitals. These are not N95 or KN95 masks, and do not claim to be.

Homedics is an American company based in the US. The masks are made in China, but these being package/labelled/overseen by US company and US distributor, the FDA has strong oversight and the ability to take actions against American companies if they falsely advertise their masks. This is not the case with all these Chinese companies and distributors who have consistently either lied in their product labeling, or who have had their approvals yanked by the FDA (including 2 different KN95 masks I bought through this site). I'd rather buy something that is more than enough for my use in public, and that is what the manufacturer states it is.

https://www.costco.com/homedics-e...67311.html
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#2
It doesn't say anywhere FDA approved
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#3
Homedics is a pretty reputable US-based company and they say the mask is FDA approved... https://www.homedics.com/ear-loop...-pack.html

Here is FDA listing for product QKR
https://www.accessdata.fda.gov/sc...fm?id=2908
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Last edited by lawshopper June 15, 2020 at 09:42 PM.
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#4
They're not N95 or KN95.
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#5
Looks like something I paid $2.80 for back in 2011. Okay, pre-pandemic, but they look identical to the SD on amazon that I am still using now.. Yes, and it was for a 50 pack.
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Fuzzy Universe
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#6
Quote from lawshopper
:
Homedics is a pretty reputable US-based company and they say the mask is FDA approved... https://www.homedics.com/ear-loop...-pack.html

Here is FDA listing for product QKR
https://www.accessdata.fda.gov/sc...fm?id=2908
QKR is a FDA's Product Classification and not an approval designation. Almost all this types of face covering made by anyone belong to this class. This seems to be added for the COVID-19 emergency period. Before CoVid-19, this type of masks are sold as surgical masks and have the FDA product class OUK that require Antimicrobial/Antiviral Agent (e.g. filter)

In fact, Homedics's statement is misleading at best and downright lying at worst.

But since Costco is selling it, purchasing risk is minimized. So as far as the deal goes, I think it is good. (Costco does not say it is FDA approved)
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#7
This is not a deal. You can get the same quality masks from WYZE for $20 shipped. https://wyze.com/face-masks.html
the 95% BFE is *not* the same thing as KN95 or N95. This will *not* "filter" COVID-19 any better than any other cheap mask. Only a respirator like an N95, KN95 or better will filter out small virus particulate.

That being said, these types of face masks are still helpful in reducing transmission by cutting down on large respiratory droplets from exiting your mouth.
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#8
Quote from lawshopper
:
Homedics is a pretty reputable US-based company and they say the mask is FDA approved... https://www.homedics.com/ear-loop...-pack.html

Here is FDA listing for product QKR
https://www.accessdata.fda.gov/sc...fm?id=2908
https://www.accessdata.fda.gov/sc...fm?id=2908

Definition Face mask is intended to be worn by general public or healthcare personnel. The mask covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels....
Product Code QKR

========================

Meaning there is no fluid barrier nor filtration efficiency level that the face mask need to meet.
So not sure what FDA approved mean if there is no standard that need to meet.
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#9
Since most of the 3-ply face mask posted in SD are made in China and more likely have China Standard mentioned on the package, here are some information about those Standard...

https://matters.news/@avengermojo...rvpmmiv734
  • Medical Face Mask ( YY/T0969)
    Basically this is a BFE (3.0 Microns Bacteria Filtration Efficiency ) >95% Mask. It is most likely a 2D flat base with 3 layers. Basically this is considered as a regular face mask that both US and Europe has higher standard requirement then this.
    Other test standards go along with this mask will include:
    GB/T 15979 for one time use hygienic standard. GB/T 16886 for In-vitro Cytotoxic, Skin Irritation /Sensitization (ISO 10993)
  • Surgical Mask ( YY/0469 )
    This mask standard is a bit mood because it is BFE > 95% and PFE ( Particle Filtration Efficiency ) > 30% only. Which doesn't match another standard in the US or Europe. But it does include the fluid-resistant test and the flammable test.
  • Protective Face Mask (GB2626–2006, GB19083–2010)
    These two standard could be confusing but their filterability is basically the same. The only difference is the fluid resistance test with GB19083. In the US NIOSH standard it should be called Surgical, and the Europian standard is Type R. Chinese has 3 levels from PFE KN95 > 95%, KN99 > 98% KN100> 99%. So KN95 is basically the same as N95, N99 similar to KN99 and N100 similar to KN100. Europian FFP1 starting with > 80% FFP2 > 94% and FFP3 >99% .
  • ASTM F2100 Level 1 2 3 (USA Standard)
    China only has Surgical Mask which is only 30% PFE and F2100 Level 1 is 95%, Level 2 is 98% and Level 3 is the same with hight fluid resistance. So you are highly unlikely to find ASTM 2 or 3 in the market unless they are US-specific factory.
  • EN14683 and EN149
    Europian Standard use their sharp to different the two standards so EN14683 is basically the Medical Mask with no PFE filter just like China YY/T0969 . has Type I, II, III and representing 95%, 98, 99% BFE. And EN149 is the cup sharp respirator with PFE over 80%, 94% and 99%.
  • Surgical and Non-Surgical
    The Europian standard surgical fluid-resistant represented by Type R at the end. For example, EN149 FFP2 Type IIR is basically the same as Surgical N95 and GB19083–2010 Level 1.

If we are going outside but not an enclosed environment, a Medical face mask should be enough to stop droplet getting into our system. Even the filter is not PFE > 95% the static of the mask will able to attract virus in the aerosol. If you are going to a room for a longer period of time, a KN95 would be better which is PFE > 95%. If you are medical front line that requires staying in a high viral loan environment for a long period of time, the N95 with a surgical face mask at the front can help extend the usage duration. For ICU it is better Surgical N95 or above and Surgical Face mask at the front or a face shield.

There is also China standard GB-T32610-2016 which is used to protect us from the air pollution like PM 2.5 particulate matters. It is not suitable for underwater work, firefighter, medical use or industry protection. GB 2626 masks are suitable for protecting from dust, mist, fume, microorganism and others. It is not suitable for hazardous gas or underwater work, firefighter work. GB 19083 masks are suitable for medical work environment. The face mask that mean this GB-T32610 standard likely the one that currently get down to $10~$15 per 50 right now. But all of these 3-ply face mask are still better than cloth mask.
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Last edited by MozartA June 15, 2020 at 11:36 PM.
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#10
Product page mentions its made with Polypropylene. This makes it surgical mask grade water resistant so its better than the cheap wyze non surgical masks. Probably same as the higher price wyze surgical masks.

There's a simple test you can do on your masks, fold mask up with outside facing up, place a few drops of water on it and the water should just sit there instead of leaking through. You can press down on the water and it still shouldn't leak through.
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#11
Comparing these to masks with made-up quality standards claimed by Chinese companies and Chinese distributors that have literally appeared overnight with no quality control or testing is nuts. Especially when most all of the companies given temporary approval by US for such uses have had their temporary approvals revoked in the last month.

Homedics is a reasonably respected American company. It is responsible for its claims just like any other American company. If they are lying, the FDA can go after them. Good luck doing the same with any Chinese company, much less the overnight Chinese pop-up companies and distributors most are buying them from.

On top of that, Costco is a very reputable company known for testing and vetting the products it sells. Costco's description clearly states:
• ≥95% BFE (Bacterial Filtration Efficiency)
• Outer non-woven fabric for anti-bacterial layer
• Middle filtration layer of melt-blown fabric

Homedics clearly states these have complied with FDA standard QKR and is Level I in Canada. This means that these masks could be legally worn in a US or Canadian facility as a surgical mask. If you think all doctors and hospital personnel are wearing K95 masks, you have another thing coming. To compare these to eBay garbage and meaningless stamps/seals/standards on the sides of a no-name company's box makes no sense.

This is the best price I've seen on this level of a mask for months. If you prefer to buy an eBay mask with a fake "CE" stamp on the side, you can probably get masks approximately half this cost.
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#12
Quote from lawshopper
:
Comparing these to masks with made-up quality standards claimed by Chinese companies and Chinese distributors that have literally appeared overnight with no quality control or testing is nuts. Especially when most all of the companies given temporary approval by US for such uses have had their temporary approvals revoked in the last month.

Homedics is a reasonably respected American company. It is responsible for its claims just like any other American company. If they are lying, the FDA can go after them. Good luck doing the same with any Chinese company, much less the overnight Chinese pop-up companies and distributors most are buying them from.

On top of that, Costco is a very reputable company known for testing and vetting the products it sells. Costco's description clearly states:
• ≥95% BFE (Bacterial Filtration Efficiency)
• Outer non-woven fabric for anti-bacterial layer
• Middle filtration layer of melt-blown fabric

Homedics clearly states these have complied with FDA standard QKR and is Level I in Canada. This means that these masks could be legally worn in a US or Canadian facility as a surgical mask. If you think all doctors and hospital personnel are wearing K95 masks, you have another thing coming. To compare these to eBay garbage and meaningless stamps/seals/standards on the sides of a no-name company's box makes no sense.

This is the best price I've seen on this level of a mask for months. If you prefer to buy an eBay mask with a fake "CE" stamp on the side, you can probably get masks approximately half this cost.
It doesn't matter. The same FDA is telling people to cut up their old underwear and make masks out of them. The point of this type of mask is not to protect you from viruses! The specs don't matter! What matters is that you are not directly emitting large droplets from your mouth or nose that can make others sick. Any face covering within reason will perform this function. Don't get caught up in the certification unless you are trying to actually filter out a specific size particle, (Covid-19) which these masks DO NOT filter even with an FDA cert.
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#13
Quote from SalmonSurprise
:
It doesn't matter. The same FDA is telling people to cut up their old underwear and make masks out of them. The point of this type of mask is not to protect you from viruses! The specs don't matter! What matters is that you are not directly emitting large droplets from your mouth or nose that can make others sick. Any face covering within reason will perform this function. Don't get caught up in the certification unless you are trying to actually filter out a specific size particle, (Covid-19) which these masks DO NOT filter even with an FDA cert.
Wrong.

Why are you even looking at a face mask post if you seriously think that "any face covering within reason will perform this function?" If you cannot see the value that a mask that stops 95% of .1micron particles beyond the general "shop" masks being sold (or reusable cloth masks) which stop <10% of .1 micron particles, then feel free to pass or to buy something else.
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#14
Quote from lawshopper
:
Wrong.

Why are you even looking at a face mask post if you seriously think that "any face covering within reason will perform this function?" If you cannot see the value that a mask that stops 95% of .1micron particles beyond the general "shop" masks being sold (or reusable cloth masks) which stop <10% of .1 micron particles, then feel free to pass or to buy something else.
You don't understand. These masks that you are advertising as a "deal" are not sealed around the sides like a N95. Same as a cloth mask, when you inhale, air comes in from the sides. That can get you sick. That's why hospitals don't use them when treating potentially infectious patients. They are used to prevent large droplets from being TRANSMITTED by catching the droplets.

You need to understand that these masks are really designed for dust and particulate that you don't want to breathe in. Not for viral pathogens. Do your research. These do not seal on the sides, air comes in via path of least resistance.

Look, it's nothing personal. I just don't want people to think these will "keep them safe". These keep other people safe. If everyone wears a face covering, we are all much safer. I don't want to argue with you, I just ask everyone to do their research and understand the difference between a N95 respirator, and a Class I face mask. They have different purposes. Caveat emptor.
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Last edited by SalmonSurprise June 16, 2020 at 10:15 AM.
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#15
Quote from SalmonSurprise
:
You don't understand. These masks that you are advertising as a "deal" are not sealed around the sides like a N95. Same as a cloth mask, when you inhale, air comes in from the sides. That can get you sick. That's why hospitals don't use them when treating potentially infectious patients. They are used to prevent large droplets from being TRANSMITTED by catching the droplets.

You need to understand that these masks are really designed for dust and particulate that you don't want to breathe in. Not for viral pathogens. Do your research. These do not seal on the sides, air comes in via path of least resistance.

Look, it's nothing personal. I just don't want people to think these will "keep them safe". These keep other people safe. If everyone wears a face covering, we are all much safer. I don't want to argue with you, I just ask everyone to do their research and understand the difference between a N95 respirator, and a Class I face mask. They have different purposes. Caveat emptor.
DIY, How to use three Rubber Bands to convert a surgical mask and improving the sealing and filtration efficiency close to N95.

https://www.youtube.com/watch?v=CVjGCPfRwUo

With their study, it show as long as you can avoid talking a lot using this method, with ASTM standard for Surgical Masks, F2100, it can greatly improve sealing and filtration efficiency that may pass as N95.

https://medium.com/@fixthemask/la...59dbb926a3

Right now 3-ply ASTM F2100 surgical mask cost around $35+ per 50 masks on ebay right now.
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Last edited by MozartA June 16, 2020 at 11:06 AM.
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