Common masks aren’t medical devices.
Common masks aren’t medical devices.
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The surgical masks that everyone is pushing on people when they enter without a mask is considered a medical device:
Face mask regulations explained ... - NS Medical Devices
Search domain www.nsmedicaldevices.com/analysis/face-mask-regulations/https://www.nsmedicaldevices.com/analysis/face-mask-regulations/
Respirator masks are considered personal protective equipment (PPE) products by both the European Union and US Food and Drug Administration (FDA), while surgical face masks are classified as a medical device.
Furthermore the Law that Horowitz cites has a very broad definition which they call “eligible product”. It doesn’t address just medical devices.
Just a second, doctor. Consider this;
How to Determine if Your Product is a Medical Device
(excerpt)
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Additionally, medical devices include in vitro diagnostic (IVD) products, such as reagents, test kits, and blood glucose meters.
Certain radiation-emitting electronic products that have a medical use or make medical claims are also considered medical devices. Examples of these include diagnostic ultrasound products, x-ray machines and medical lasers.
What say you?