Dr Max 3 Ply Surgical Masks 50 Pack $30 + Free Small Hand Sanitiser + Free Shipping Aus Wide
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Dr Max 3 Ply Surgical Masks 50 Pack $30 + Free Small Hand Sanitiser + Free Shipping Aus Wide
Limited Time Offer
Perhaps it deters the French
Registered, not Approved.
There is a difference
lies about the product is a bad sign
It's not a lie per se, it's ignorance of the law. It's amazing how many ARTG mask sellers haven't bothered to read the rules.
https://www.tga.gov.au/face-masks-and-respirators-are-regula…
Face masks that are regulated by the TGA
Face masks meet the definition of a medical device when the following claims are made:
The face mask is to be used for the prevention of the transmission of disease between people, or
The face mask is suitable for therapeutic use such as for surgical, clinical, medical use, or use in other health services.
If the manufacturer's labelling, advertising, or documentation contain the claims above, the face mask is considered to be a medical device and is required to be included in the ARTG.
Though not a requirement, the ARTG number may be included in the labelling or on the packaging.
To his credit this seller has amended his website immediately. Unlike MANY mask sellers he has paid the TGA fee and made his product available for testing should the TGA ask as part of its post-market review. Meantime others continue to mislead consumers with mentions of "surgical/medical" and break the law by not registering their products. You decide who deserves support.
No deal
$4.99 delivered from here and $10 Australia wide shipping
https://citymartmelbourne.com.au/product/3-ply-disposable-fa…
Unless they've overlooked the ARTG they are also in contravention of TGA rules. ALL masks labelled as "surgical" are required to be registered on the ARTG.
Row 11: https://www.tga.gov.au/face-masks-and-respirators-are-regula…
Claim / labelling
Labelled as a 'surgical' or 'medical' mask or respirator.
TGA interpretation
This is representative as suitable for use in surgery, or clinical, medical or other health services.
ARTG required?
I work for a health service, Victoria have over 3 million 'non-clinical' masks being used in health services - admittantly not in surgery spaces.
Chinese manufacturing mis-labelling / chinglish at play
Mask supply was problematic a few months ago, not so now, which is why the TGA has issued guidelines. The law is the law and sellers like the one you linked are breaking it either through ignorance or because they couldn't give a fig.
Box says the country of manufacturer but no mention of the manufacturer — Caveat emptor.
The seller provided the ARTG number.
Cool. So the manufacturer is "Hubei Healthcare Protective Products Co., Ltd.".
I do not see this manufacturer in the FDA's Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated: September 4, 2020)
Does the anti-frog nasal strip protect the wearer from amphibian viruses?