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FDA withdraws approval of some mask makers in China to sell in U.S
Reuters ^ | May 7, 2020 | by Manojna Maddipatla

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 FDA’s 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 hadn’t 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 ...


TOPICS: Business/Economy; Foreign Affairs; Government; News/Current Events
KEYWORDS: ccp; china; pandemic; ppe
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1 posted on 05/07/2020 12:55:27 PM PDT by Oldeconomybuyer
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To: Oldeconomybuyer

Some? Why not ALL?


2 posted on 05/07/2020 12:56:45 PM PDT by CatOwner
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To: Oldeconomybuyer

How about Zero, Nada, Zip, Fin?


3 posted on 05/07/2020 1:09:21 PM PDT by Vendome (I've Gotta Be Me https://youtu.be/wH-pk2vZG2M)
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To: Oldeconomybuyer
China has shown it has quality control problems with a lot of their products. We should require 100% quality control testing of all their products before they are allowed into the country.

That ought to shut them down for a while. No more cheap/shoddy crap from China or the rest of the world.

4 posted on 05/07/2020 1:10:39 PM PDT by rllngrk33 (The only thing government does effieciently is waste taxpayer money.)
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To: CatOwner

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.


5 posted on 05/07/2020 1:19:30 PM PDT by sanjuanbob (Yes, I CAN take a joke /s)
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To: Oldeconomybuyer

Seriously, aren’t we capable of making enough masks in America?


6 posted on 05/07/2020 1:21:59 PM PDT by 1Old Pro (#openupstateny)
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To: Oldeconomybuyer

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.


7 posted on 05/07/2020 1:26:34 PM PDT by Fresh Wind (This tagline is an advertisement-free zone. Is yours?)
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To: Oldeconomybuyer

Screw masks! It’s all about the bandanna

Every single person in the old west had a bandanna they didn’t have some stupid mask

In fact it would they would say about the lone ranger who were a bandanna who was that masked man?


8 posted on 05/07/2020 1:30:33 PM PDT by Truthoverpower (The guv mint you get is the Trump winning express !)
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To: CatOwner

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.


9 posted on 05/07/2020 1:37:09 PM PDT by ETCM
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To: Truthoverpower
the lone ranger who were a bandanna

No. The Lone Ranger certainly did not wear a bandana.

He wore a cute masky.

10 posted on 05/07/2020 1:48:06 PM PDT by corkoman
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To: Oldeconomybuyer
China Baffles Canada With Claim A Million Defective Masks Were A ‘Contractual’ Issue
11 posted on 05/07/2020 1:50:53 PM PDT by blam
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To: Oldeconomybuyer

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.


12 posted on 05/07/2020 1:52:21 PM PDT by wetgundog
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To: corkoman
I can still hear, 'this way Tonto follow.'
13 posted on 05/07/2020 1:52:31 PM PDT by blam
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To: Oldeconomybuyer

14 posted on 05/07/2020 1:55:06 PM PDT by CodeToad (Arm Up! They Have!)
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To: wetgundog

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.


15 posted on 05/07/2020 1:58:58 PM PDT by lodi90
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To: Oldeconomybuyer
China Dairy Products Found Tainted With Melamine

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.

16 posted on 05/07/2020 2:01:16 PM PDT by blam
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To: Oldeconomybuyer

Made In China labels should be edited to read “Toxic Useless Junk That Was Made In China”.


17 posted on 05/07/2020 2:44:15 PM PDT by Arcadian Empire
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To: Oldeconomybuyer

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.


18 posted on 05/07/2020 2:46:02 PM PDT by jdsteel (Americans are Dreamers too!!!)
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To: Oldeconomybuyer

The only thing we should be allowed to import from China is tea and porcelain


19 posted on 05/07/2020 2:48:17 PM PDT by RedStateRocker (Nuke Mecca. Deport all illegals. Abolish the DEA, IRS and ATF,.)
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To: Fresh Wind

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.


20 posted on 05/07/2020 2:53:16 PM PDT by EBH (May God Save Our Freedom from our enemies within)
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