Only 50 boxes available.
Layer: 3-Ply
Colour: Blue
BFE: >=98%
Medical Level 2
ARTG Identifier: 339478
50 Pack 3-Ply Face Masks (Level 2 Medical) $17.95 Delivered @ FSOnline
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AssociatedFSOnline on 23/01/2021 - 19:48 fortunestar.com.au (402 clicks)
Last edited 26/01/2021 - 11:04
Last edited 26/01/2021 - 11:04
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No.
Here’s the ARTG document for them
https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=43A27A08C8641B93CA2585A500422BCC&agid=(PrintDetailsPublic)&actionid=1
thank you for clarifying this on the website:
• 100% Brand New
Are these TGA Registered or TGA listed?
Neither for this kind of product.
If it's got an ARTG # and it's a medical device, the acceptable terminology is simply 'entered' into the ARTG. To state otherwise, it can be misleading, particularly to consumers who just wants a good face mask.
The device is Class I also (lowest risk classification; I.e. the higher the risk classification, the more scrutiny/review is needed). By saying "TGA Registered Facemasks", the wording in the title implies government endorsement and the TGA does not endorse anything, so what the seller is stating is simply non-compliant if reported.
I don't normally comment on things like this but it irks me to see that people might buy products with a certain perception of confidence based solely on a sellers' presentation when in fact, it's inaccurate/untrue. It's good to see not all sellers are doing this and play fair game with their advertising.
Here are some links for those interested in some night time reading:
Do not say TGA 'registered' :
https://www.tga.gov.au/book-page/advertising-and-endorsement…Device inclusion process:
https://www.tga.gov.au/book-page/step-4-submitting-applicati…Correct. The OP is not permitted to refer to TGA in its advertising.
I swear the masks were level 1 yesterday….
Are these Australian made