Posted on 05/07/2020 12:55:27 PM PDT by Oldeconomybuyer
The U.S. Food and Drug Administration on Thursday announced that it has canceled the approval for some manufacturers in China to sell N95 respirators in the United States, as they failed to offer adequate protection against the new coronavirus.
A number of these respirators failed to demonstrate a minimum particulate filtration efficiency of 95% upon testing, the agency said.
The FDAs move on Thursday follows its decision last month to ask China to revise new export quality control rules for protective equipment needed, so they are not an obstacle to timely supplies.
The agency said it had previously authorized the use of those respirators manufactured in China that have been tested by a recognized independent laboratory, even if they hadnt been tested by U.S. authorities.
However, as a number of these respirators failed to meet the minimum performance standards, the FDA said it was withdrawing the approval of all respirators authorized under the previous criterion.
(Excerpt) Read more at reuters.com ...
Some? Why not ALL?
How about Zero, Nada, Zip, Fin?
That ought to shut them down for a while. No more cheap/shoddy crap from China or the rest of the world.
You’re totally right, but they don’t do anything for you whether they’re official N95 or knockoffs. Waste of money.
Agree, beware of China.
Seriously, aren’t we capable of making enough masks in America?
I really wish someone would publish a list of those manufacturers and trade names associated with non-compliant Chinese masks.
I bought some a while back that were claimed to be N-95, but I have my doubts.
Screw masks! Its all about the bandanna
Every single person in the old west had a bandanna they didnt have some stupid mask
In fact it would they would say about the lone ranger who were a bandanna who was that masked man?
CA Gov Newsom paid cash in advance for millions of masks from Chinese company BYD, who has never produced them before. They’re not on the “bad list” yet, because the FDA has never tested or seen one of their masks. However, the FDA has stepped in and told CA that they cannot use the masks until they are tested and certified by FDA/NIOSH. BYD must not have had much confidence in their new N95 respirators, as they cancelled shipment while they “ensure the masks meet standards”. I bet they are marked NIOSH with no actual certification. Basically, China is shipping counterfeit medical equipment around the world.
No. The Lone Ranger certainly did not wear a bandana.
He wore a cute masky.
More JUNK from China, as an engineer who has worked medical device Quality in China, they are all Liars and will get away with everything that can by lying through their teeth.
I am third generation American of Chinese descent, so I cannot be called a racist for this. Bring all manufacturing out of China and back in the USA like your life depended on it, because it does.
There should be a ban of PPE imports from Communist China. Now is the time to force changes in the supply chain. It will never happen otherwise and we’ll be in the same position the next time a bad bug hits us.
They added the industrial chemical melamine to the baby formula so that it would pass the government mandated protein content specification. Many babies died.
The UK had to pass a law limiting the amount of baby formula that could be bought because the local Chinese were sending it all to China causing a shortage in the UK.
Made In China labels should be edited to read “Toxic Useless Junk That Was Made In China”.
Medical PPE and devices should be put on a list of Vital American Industries. There should be tax benefits (like our Free Enterprise Zones) and streamlined regulations. Penalties for wrongdoing should be multiples of what they are now.
Then, slowly expand the list to everything.
The only thing we should be allowed to import from China is tea and porcelain
It’s the KN95 masks that were recalled.
SEMA said the recalled masks may bear the names Huabai, SANQUI, or be unmarked, with Chinese characters on the cellophane packaging, or other names.
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