N95 NIOSH Approved Markings
#15,318
As if a pandemic virus weren't enough of a health hazard, we continue to get reports of substandard - and even contaminated - N95 (like) or surgical masks being sold both online, and in stores. While some of these problematic PPE have come from Turkey, India, and other Southeast Asian counties, the vast majority of them appear to come from China.
This morning Hong Kong announced yet another seizure of `KN95' masks - which while sold as `new in box' - exceeded the legal bacterial count.This isn't the first such seizure in Hong Kong, and according to media reports on a lawsuit filed by 3M against Chinese manufacturers of fake N95 masks, thousands of vendors have been removed by Amazon for selling knockoffs at exorbitant prices.
It isn't clear from Hong Kong's reporting how these masks became contaminated with bacteria, but they warn consumers not to use masks that are soiled, stained, or have an odd smell. One can't help but wonder if some of these masks - sold as new - are actually used (and hopefully) decontaminated masks.
First some excerpts from today's announcement, then I'll return with a bit more:
Hong Kong Customs urges public to stop using one type of surgical mask suspected of exceeding bacterial limit (with photo)
Hong Kong Customs today (June 12) appealed to members of the public to stop using one type of surgical mask as test results revealed that the bacterial count of the mask exceeded the maximum permitted limit, in contravention of the Consumer Goods Safety Ordinance (CGSO). Traders should remove the product from shelves as well.
Customs yesterday (June 11) received the test results of the latest batch of 38 test-purchased surgical mask samples. According to the relevant hygienic standard for disposable sanitary products, the total bacterial count of the sample of one type of surgical mask exceeded the maximum permitted limit by 25 per cent, in contravention of the CGSO.
The surgical mask concerned was packed in boxes of 10 pieces each with individual packaging and was sold for $180. The manufacturing place is China as marked on the box. Customs officers test-purchased the mask from a pharmacy in Tsim Sha Tsui in May this year.
(SNIP)
Apart from the sample announced in this round, Customs has also announced a further nine types of surgical masks with bacterial counts exceeding the maximum permitted limit on March 14, April 17 and June 3, of which the total bacterial counts exceeded the maximum permitted limit by 20 per cent to 11.5 times.
Customs again reminds members of the public to observe the following tips when purchasing and using surgical masks:
- Check if there is any dirt on the masks and stop using those with stains or odd smells;
- Pay attention to the proper way of using surgical masks;
- Change surgical masks at a suitable time;
- Store surgical masks in dry places; and
The "Guardian" operation has been running for over four and a half months to date. More than 5 100 officers have been mobilised to conduct over 33 000 inspections at retail spots in various districts to ensure that common protective items sold in the market comply with the CGSO and the Trade Descriptions Ordinance.
- Purchase surgical masks at reputable retail shops.
Ends/Friday, June 12, 2020
Chinese made KN95 masks - while not fully meeting the quality control standards of NIOSH certified N95 masks - are a temporarily allowed substitute for healthcare workers in the United States under an EUA (Emergency Use Authorization) by the FDA.
At the same time, the FDA recently issued a letter to healthcare providers warning:
Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory ProtectionThe problem is, while some Chinese manufacturers are producing reasonably reliable products, others are clearly not. On June 9th the FDA issued a letter listing 66 manufacturers of N95/KN95 masks that are no long authorized by the EUA.
How many of these sketchy masks are currently in use, or sitting in hospital supply closets around the country, is unknown.NIOSH maintains a fraudulent N95 Respirator website, listing known knockoffs.
Counterfeit Respirators / Misrepresentation of NIOSH-Approval
Updated June 5, 2020
Counterfeit respirators are products that are falsely marketed and sold as being NIOSH-approved and may not be capable of providing appropriate respiratory protection to workers.
When NIOSH becomes aware of counterfeit respirators or those misrepresenting NIOSH approval on the market, we will post them here to alert users, purchasers, and manufacturers.
How to identify a NIOSH-approved respirator:
NIOSH-approved respirators have an approval label on or within the packaging of the respirator (i.e. on the box itself and/or within the users’ instructions). Additionally, an abbreviated approval is on the FFR itself. You can verify the approval number on the NIOSH Certified Equipment List (CEL) or the NIOSH Trusted-Source page to determine if the respirator has been approved by NIOSH. NIOSH-approved FFRs will always have one the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100.
Signs that a respirator may be counterfeit:We've known for more than a dozen years that our national stockpile contained less than 2% of the N95 respirators and surgical masks that would be needed for a severe pandemic (see 2009's Caught With Our Masks Down) - and that global resupply during a pandemic would be impossible - and yet no one did anything about it.
Additional Tips for Spotting Counterfeit Respirators Before You Buy
- No markings at all on the filtering facepiece respirator
- No approval (TC) number on filtering facepiece respirator or headband
- No NIOSH markings
- NIOSH spelled incorrectly
- Presence of decorative fabric or other decorative add-ons (e.g., sequins)
- Claims for the of approval for children (NIOSH does not approve any type of respiratory protection for children)
- Filtering facepiece respirator has ear loops instead of headbands
While I don't really expect to see any accountability for these lapses, it would be nice if we could at least avoid a repeat for the next pandemic.
