Apple winning in industries they aren't supposed to be in.
The competition is essentially homemade DIY crap. Not a high bar to clear.
Fortunately, we can buy real, disposable masks now -- like the people in Asia have had all along. They filter better and are more comfortable. It will be interesting to see how the Apple Mask stacks up against them (although I'd be surprised to see any fact based comparisons.)
FDA CLEARED don’t mean much. Anyone can create something and send to FDA and explain the something works similarly to other thing got FDA approved. Then the something will get cleared.
This is a major loophole of FDA. The new products will not go through the very strict, time consuming and super expensive approval procedures as a brand new medical product.
You are wrong. Even for Class I devices you still need data, you still need to prove that it performs similarly to an existing approved device. And if you claim that the device is sterile, be prepared to prove that it is, and that your sterilization method is valid and reproducible and you've done the quarterly audits to verify this.
"Oh my god, you people are all Apple sheep, why are you buying this overpriced mask when you can get better performance from a mask that's $X cheaper..."
"Oh my god, you people are all Apple sheep, why are you buying this overpriced mask when you can get better performance from a mask that's $X cheaper..."
Comments
There is no "major loophole".
/s