KN95 masks. Down from $33.22 to $23.99.
Disposable with earloop
5 Ply filtering production
High filtration capacity
Protects against bacteria, dust, etc
Comfortable and breathable
Nose bar adaptable
KN95 Face Masks (10 Pack) $23.99 + Delivery @ The Nile
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AssociatedLyangatchi on 23/08/2020 - 16:33 thenile.com.au (174 clicks)
Last edited 23/08/2020 - 17:13 by 1 other user
Last edited 23/08/2020 - 17:13 by 1 other user
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No TGA registration for any products matching the word "BIIO". Description is deceptive.
Downvoting for this
Not that I'm defending the product - but to be fair, I don't think "BIIO" has to come up with something. BIIO is just a trademark, it tells you nothing about the manufacturer nor the name of the company.
If you look at the registrations for face masks, they pretty much all have generic product names.
A fair statement, but doesn't apply in this case. The manufacturer is BIIO Global Ltd. According to the WHOIS record for biio.tech, the company is actually part of Goddess International Ltd in Hong Kong. The BIIO website claims the mask is FDA approved, but neither BIIO Global Ltd nor Goddess International Ltd have any FDA registrations, and doesn't appear in the NIOSH CEL (since the FDA isn't the correct regulator for masks anyway).
Yeah screw this guy then! Getting my pitchfork out
ARTG No: 340390
Ok, and that is what? The manufacturer in that ARTG entry isn't either of BIIO Global or Goddess International, and the BIIO website doesn't mention "Fujian Qifeng New Material Technology Co Ltd" anywhere. You may as well be linking to Rick Astley videos for all the value it has.
BIIO is the brand of the item. The manufacturer is the one listed in the TGA entry.
@yangatchi: Can you provide some evidence of that statement? I'm certain if what you say is true that somewhere on the box it should say the manufacturer's name.
@[Deactivated]: The TGA requires a number of pieces of documentation, which they use to assess the items being submitted. If these meet their requirements an ARTG entry is issued. Had they not issued this entry the masks would not have been allowed to be imported into Australia.
@yangatchi: Wrong answer, and totally false. It's illegal to sell therapeutic products without an ARTG entry, but nothing stops unscrupulous businesses doing so anyway.
However, the TGA does not care about non-therapeutic products, and the box does say "non-medical device" so the TGS wouldn't care if you certified it or not.
@[Deactivated]: I can't speak for what unscrupulous businesses will do. I can only tell you how we went about this.
We approached the TGA at the point of importing the masks. They advised they would be classified as Class 1, and would require certification. We undertook the necessary steps, and were awarded the ARTG entry numbers for these items. We have subsequently been able to import these items, without having them held at customs or refused entry. On the ARTG entry you will find our company as the sponsor.
@yangatchi: That's wonderful, the issue is not that you did or did not sponsor an ARTG entry for a mask product, the issue is that you dodge showing anything to prove that what you're selling is that product. You can't just make a claim that your mask product is TGA certified, post a picture of a mask prominently labeled "BIIO" which has an official site claiming the product is manufactured by "BIIO Global Ltd", and then claim it's TGA registered on the basis of an ARTG entry for "Fujian Qifeng New Material Technology Co Ltd".
I'm mystified as to how you cannot think that looks dodgy, and how you miss the obvious solution of just showing something to prove the ultimate manufacturer of BIIO's products is Fujian Qifeng New Material Technology Co Ltd - because BIIO sure doesn't on their website.
The tag (above) says "Surgical Mask", however, the box specifically states "non-medical device".
Non medical just means they are non sterile so yeh not for a surgical setting but its what we call them
Non medical just means they are non sterile
Yeeeah. Nah. Incorrect. Non-medical literally means not medical device, or in other words, do not comply with the Therapeutic Goods Act and not registered in the Australian Register of Therapeutic Goods.
In yet other words, non-medical means it's either garbage or not, but no one officially said otherwise.
Furthermore, many medical devices are not sterile, but I will refrain from going into details on the differences between sterile and disinfected. I fear my words would be lost on you.
The fakery from this from certain quarters is amazing. Even the name is trying to fool the unsuspecting.
My understanding is that the TGA is not responsible for developing mask standards but rather the National Institute for Occupational Safety and Health (NIOSH).
In any event, n95 is the standard in the US, not nk95.
I suspect someone is telling some porky pies in this listing.
NIOSH is the institution making mask standards in the US, whereas TGA is the standard group in Australia. Masks from one country (KN95) can meet the standard for another country. but they do need to be certified by the relevant standards group, and have the correct markings.
For people looking to tell Fake from Real P2/N95/KN95/FFP2 masks, here are some professional guides
https://www.aioh.org.au/static/uploads/files/guide-p2-respir…
http://www.bohs.org/wp-content/uploads/2020/05/Spotting-a-Fa…
https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.…
What is the TGA number?
ARTG No: 340390
Spam
ARTG No: 340390
ARTG ID: 340390
Product name: Mask, surgical, single use
Sponsor: Mercury Retail Pty Ltd
Manufacturer: Fujian Qifeng New Material Technology Co LtdI can see that the item is a "mask, surgical" but the box specifically states "non-medical device".
Next, I do not see the manufacturer in the latest (21 August 2020) list of Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China.
NIOSH is only relevant to the US market. They don't regulate Australia. That said the manufacturer does claim "FDA approved" (which it is not).
Ooooooo … `nother one!