August 24, 2020

KN95 5 Layers Respirator Face Mask No Longer FDA Approved

Thank you Lisa for telling me that the masks that I posted about last week are no longer FDA Approved. I purchased them at MaskSheets and they are still showing as being FDA Approved however, Lisa pointed me to this link: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas which shows their FDA Approval was removed. The company name is Fujian Pageone Garment.

I’ll likely discontinue using these masks and start searching for some new ones!

If anyone has some recs please let me know.

I’ll let you know as soon as Masksheets removes the FDA Approved status on their website.

Thanks again Lisa!

25 Comments

About the Muse

Isabella MuseIsabella is just an average everyday geeky girl who doesn’t blend her eyeshadow correctly, wears too much blush, and hopes she never finds her holy grail products because she likes the thrill of the chase so much. Her mission is to bring you super honest reviews on makeup, skincare, fragrance and all things beauty. She’s in no way an expert on the topic and she sure as hell isn’t a super model. But she’s passionate about makeup and is seeking like-minded individuals that like pina coladas, getting caught in the rain, and ones that enjoy spending hundreds of dollars at Sephora without feeling buyer’s remorse. If you’re that person feel free to reach out and leave a comment or follow me on Facebook, Instagram, Twitter, and Bloglovin‘.

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Comments

  • Dee

    Seems I read last week that a cloth mask with two or three layers are the best. Nothing stretchy. Old Navy has some good ones and I’ve found some on Esty as well.

  • DiDi

    The Tommy Copper ones are really comfortable and fit well. They are rather expensive though at 19.50 for a pack of 2 but well worth it

  • Gloria

    I actually ended up buying these KN95 masks from https://bonafidemasks.com/Powecom-kn-95/ because the masks from Masksheets are no longer FDA approved. The manufacturer is Guangzhou Powecom Labor Insurance Supplies Co., LTD. which is on the FDA’s list of approved manufacturers. The seller’s site might look a bit sketch since they just started selling masks when the pandemic hit (but then again, so has many other legitimate sources). But look them up on Reddit, they seem very knowledgeable and they are on the approved list of distributors from the manufacturer themselves http://www.powecom.com/distributors-KN95_masks.html Hope this helps!

    • Lisa

      Thank you for this! I was looking at the same thing and wanted to see what others think. I’m going to buy a pack to try also.

  • Cindy

    I ordered 3 packs of these :(. I emailed them and they are going to refund me on the unopened ones and not charge me return shipping. IMHO they should refund the whole order because they misrepresented the masks as FDA approved when I bought them when they weren’t, but ‍♀️.

    • Isabella Muse

      I’m sorry Cindy 🙁 I emailed them twice already! Once Saturday and once today asking them to remove the FDA approval as it’s still on the site! 🙁

        • Isabella Muse

          curious! been loading and reloading to see if they take it down! they really should.

          • Randi Macdonald

            You can always dispute with your credit card company.

    • Gloria

      That’s what they offered to me too. Luckily, I haven’t opened any of mine yet but they will likely take it back to sell to some poor soul who might not know. I’m hoping they’ll remove the FDA approved description soon so people know what they’re getting.

  • macro

    I had purchased another KN95 mask brand and noticed that their new packaging no longer had “FDA” approved printed and thought that is strange even though the masks were the same. I didn’t know that this was happening and just tells us how you cannot trust these mask making companies.

    • Isabella Muse

      It’s really hard to tell which are legit and which aren’t! I’m sticking to my washable masks for now and when I need extra protection just going to put a blue surgeon mask on top!

  • Eileen

    Keep me updated about the masks please. It keeps getting more and more confusing Thanks.

  • StillPedaling

    Hey there, sunshine! The masks they’re referring to are not approved in a healthcare setting. None of the masks for personal use are going to be approved. Pretty sure my masks from Bloomingdales aren’t approved either… All you need is a face covering for personal use.

    • Isabella Muse

      thanks but thought I should warn anyone that purchased and planned on using in a setting where covid could be rampant!

      • StillPedaling

        Not sure how these were even passed off as N95 masks… I guess that’s why they put a “K” in front of it. These look nothing like a true N95. We have a construction business and have (had) N95 and P100 masks (all were donated to local healthcare professionals). The masks they’re passing off aren’t even good knock offs. Sad that people are that pathetic that they make knockoff face masks. 🙁 You just need a face covering.

        • Chris

          KN95 differs from N95 in that they are softer and able to mold better on the face. The N95 are firmer in structure. Both block viruses and the N95 is used in hospital settings.

          • Andrea

            Makes sense. My mom has some N95 masks because she has Cystic Fibrosis. She let me try one the other day before going out, that thing was so stiff it was uncomfortable! But she has them to protect her from everyone else as she is highly susceptible to respiratory pathogens.

  • Kimberly Thibodeaux

    They are fine for PERSONAL use. That being said, I just watched a Today Show segment on masks, and Surgical Masks are almost as effective as the N95’s and MUCH cheaper.

    My husband wears them in his clinical setting with no problems.