Sunday, January 16, 2022

How to Get Your At-Home Covid-19 Test Covered by Insurance (WSJ)

 


Biden administration wants to make rapid coronavirus screening more accessible and affordable. Shortages of over-the-counter Covid-19 tests have left some Americans empty-handed and without access to testing in recent weeks, as the Omicron variant has spread and cases have surged. Some families have paid hundreds of dollars out of pocket for the tests. 

Private insurers must cover the cost of over-the-counter Covid-19 tests starting Jan. 15 under a Biden administration plan that aims to make screening for infections more affordable for some 150 million Americans with private insurance.  Here is what we know about the administration’s test distribution and coverage plans. 

I can’t find an at-home Covid-19 test. Will more be available soon?

Hopefully. The Biden administration last fall committed $3 billion to help increase Covid-19 rapid-testing supplies. More at-home tests have recently gotten authorization from the Food and Drug Administration, and other manufacturers have increased production. Researchers at Arizona State University and elsewhere estimated on Jan. 12 that the monthly capacity for over-the-counter, at-home antigen tests will increase from 260 million tests in January to 355 million in February and 526 million in March. 

The administration is also buying and distributing 500 million at-home Covid-19 tests  upon request for home delivery to all Americans, starting Jan. 19. The tests can be ordered on the website COVIDTests.gov or via phone. Initially, the public will be limited to ordering four tests per residential address, and tests will ship via first-class mail within seven to 12 days of ordering. The White House also said it would procure an additional 500 million tests.  Demand has jumped in recent weeks amid the Omicron surge, but the rate of new infections will peak at some point, making it more difficult to anticipate how demand for tests might change in the weeks and months ahead. 

What at-home Covid-19 tests are available? Which tests will be covered by insurance?

There are two types of over-the-counter Covid-19 rapid tests available. The most common is an antigen test, which hunts for pieces of viral proteins. This category includes tests such as BinaxNow, QuickVue, Flowflex and others. To use the tests, people swab themselves about halfway up their nose, add their sample and a liquid solution to the test strip and get results within minutes. There is also another, PCR-like molecular test that searches for the virus’s genetic material. A handful are available over-the-counter. The policy doesn’t make a distinction between antigen and molecular at-home tests, so both kinds of tests will likely be covered under the new policy.

How much do at-home Covid-19 test kits cost? Is there a limit to the number of tests that will be covered? 

Prices for at-home antigen tests range from about $8 to $40 for a single test. Many are sold in kits of two for around $24 per kit. The PCR-like tests are more expensive, at about $75 a test.  Under the Biden administration’s policy, insurers will cover up to eight of these nonprescription tests a month per person. A family of four, with everyone under the same insurance plan, would get up to 32 tests covered a month. Keep in mind that some tests come in boxes of two tests, so a person would be reimbursed for four such boxes. There is generally no limit on the number of Covid-19 diagnostic tests that are reimbursed if they are ordered or administered by a healthcare provider, government officials said. 

Will I have to pay for my test up front? 

Maybe. The test may be free over-the-counter when you purchase it. Or, you might have to submit a claim for reimbursementin which case you should save your receipts. Insurers and retailers are still figuring out how to set up their policies and the process. The Biden administration is encouraging insurers to set up partnerships with retailers that would enable people to get the tests without paying up front or submitting a claim for reimbursement. If insurers develop these partnerships, people could still purchase tests from outside their network, but reimbursement would be capped at $12 per test. 

If health plans don’t set up such partnerships, they are required to reimburse the full cost of the tests. “Some companies might make it easy and have an easily designed web-portal,” said Sabrina Corlette, founder and co-director of the Center on Health Insurance Reforms at Georgetown University’s McCourt School of Public Policy. “For others, they could make it really cumbersome.” 

Consumers who believe their insurer isn’t complying with the new guidance can submit complaints to the Department of Health and Human Services, the Labor Department or their state, according to the Centers for Medicare and Medicaid Services. How long it takes to get reimbursed can also depend on how efficiently consumers upload paper receipts online or file them by mail, said Ceci Connolly, president and chief executive of the Alliance of Community Health Plans, which represents nonprofit health plans. Companies will have to review those submissions before making reimbursements.  “That’s really hard to imagine that going smoothly,” Ms. Connolly said. “What do you do with a person that has a whole bunch of receipts?” 

Are there partnerships between insurers and retailers?

Some insurer groups have said they are working to quickly implement the guidance. More specific partnerships will likely appear in the coming days and weeks. “Saturday is going to be very difficult for most,” Ms. Connolly said. 

Can I get reimbursed for tests I need to take for work? 

Not technically. Plans aren’t required to cover or reimburse employer-mandated Covid-19 testing, according to the Centers for Medicare and Medicaid Services. But it will likely be difficult for insurers to distinguish between a test purchased for medical or screening purposes versus a test purchased for employer requirements. “It’s totally unrealistic to think that health plans are going to be able to sort out the reason for people going and getting their eight free tests a month,” Ms. Connolly said. Insurers can require people to confirm they aren’t getting tests for work-related purposes, according to a CMS representative.

What if I already bought and paid for an at-home test? Can I still get reimbursed? 

Probably not. Plans and insurers are required to cover over-the-counter Covid-19 tests only starting Jan. 15. But some could provide coverage for tests purchased earlier, and some states might already have existing requirements, according to CMS. 

Do Medicare and Medicaid cover at-home Covid-19 test kits?

Medicaid and the Children’s Health Insurance Program are required to cover FDA-authorized at-home Covid-19 tests, according to CMS, though coverage rules may vary by state. Medicare Advantage plans may offer coverage, but Medicare isn’t required to cover over-the-counter tests. The Biden administration said HHS is providing up to 50 million free, at-home tests to community health centers and Medicare-certified health clinics and has established free community-based pharmacy testing sites. Medicare also pays for diagnostic tests that are analyzed in a laboratory and ordered by a healthcare provider. 

What other testing options do I have? 

In addition to at-home, over-the-counter tests, people can also get laboratory-based tests, the most common being a PCR test. Many doctor’s offices, hospitals and laboratories can perform PCR tests, and many states and cities have their own testing sites. Some also have rapid tests and sometimes give them away free. Most of the tests use some sort of nose swab, but there are some tests that use saliva as well. There are also mail-in test kits, where a person can swab their sample at home and then send it into a laboratory. Testing has been harder to come by overall in recent weeks, with appointments at pharmacies booked up days in advance or hours-long wait times at free testing sites. State or local health department websites, as well as those of your local medical center or hospital, often list nearby testing options. 

This article from the Wall Street Journal may be updated.

Write to Brianna Abbott at brianna.abbott@wsj.com

The latest guidance on what to do and where to get the supplies you need, selected by the editors:

How and When to Test for Covid-19

What to Do if You Test Positive

How to Find Covid-19 Home Tests Online

How to Get Your At-Home Test Covered by Insurance

How Reliable Are Rapid Tests for Omicron?

Are We Testing Wrong for Omicron?

Why Cloth Masks Might Not Be Enough

Do We Need N95 Masks to Protect Against Omicron?

 


Saturday, January 15, 2022

Can You Reuse a N95 or KN95 Mask? Experts Say Yes, but Follow These Steps (Smithsonian Magazine)

 


When putting on or taking off a mask, handle it by the edges or straps to avoid contamination. With the highly contagious omicron variant of Covid-19 raging across the country, public health experts are encouraging Americans to upgrade their masks from cloth face coverings to an N95 or KN95 mask.

But these face masks can only be reused for a short period of time, leaving many wondering if and how they can safely reuse their N95 or KN95 face mask. Here are tips from experts on getting the most out of your KN95 or N95 mask:

Use Good Form

When putting on a new mask, check for a snug fit around the mouth, nose, and chin. Most N95 or KN95 masks are made of a fabric-like web of synthetic polymer fibers designed to ensnare virus particles. The main difference between the two masks is that N95 masks are the standard in the United States, while KN95s are the standard in China. N95s are also approved for use in medical settings in the U.S.

Once your mask is on, avoid touching your mask as much as possible. One common error is pulling down a mask to talk to others, which creates multiple opportunities for contamination. When taking your mask off, keep away from the front and inside of the mask. Instead, handle it by the edges or straps. After removing your mask, thoroughly wash or sanitize your hands.

"Definitely avoid the part right in front of where you breathe, like right in front of your nose and mouth," says Linsey Marr, a professor of civil and environmental engineering at Virginia Tech, to Kristen Rogers for CNN

Take a Sanitation Break

Unlike the cloth masks recommended earlier in the pandemic, N95 or KN95 masks can’t simply be tossed in the laundry. Because the masks have a special static charge that traps viruses, they should never be washed.

Virus particles trapped in the respirator will die off over the course of hours to days, so experts recommend letting an N95 or KN95 mask hang out in a cool, dry place for a day or two between outings.

A simple method for implementing this resting period between uses is to put your mask in a brown paper bag for 24 to 48 hours before using it again.

“The concern about wearing a mask in public, obviously, if you get particles on it, perhaps even the virus, but if you store it in a dry bag, you are essentially sanitizing again over a period of time,” says Joe Gastaldo, an infectious disease expert at OhioHealth, to the Miami Herald’s Bailey Aldridge.

Sabrina Assoumou, an infectious disease physician at Boston Medical Center, recommends having multiple masks in a rotation, so each mask can have a sanitation break between uses. Individuals can then label the bags accordingly to keep track of each mask.

"For an N95, we'd recommend you switch [the mask] every day," says Assoumou to Felicity Warner for USA Today. "But, you can rotate them. If you have three masks, [for example], you could number them and switch them around."

Check for Wear and Tear

Because masks deteriorate at different rates, it’s a good idea to regularly check a mask’s fit and function before you use it. Look for signs of stretched-out straps, stains, soiling, or fraying of the mask—all of which compromise its ability to filter out Covid-19.

The longer and more frequently you wear an N95 mask, the more contaminated it can become, and the sooner it will need to be replaced. A front-line worker wearing an N95 mask for a day-long shift may find their mask is compromised after one use, while someone dining with a mask or wearing one for a trip to the grocery store may find they can get multiple uses out of it.

"If you're rotating your masks, washing your hands and storing them well, you can get five to a little bit more uses with them," Gastaldo says to USA Today.

The Centers for Disease Control and Prevention (CDC) recommends using N95 respirators for no more than five uses, noting that each time an N95 is removed and put back on, it weakens and stretches the masks’ straps. Per CDC guidance, health care workers should not reuse respirators.

“Really, it's going to get gross from your face or the straps will get too loose or maybe break before you're going to lose filtration ability," Marr says to CNN.

Known When It Has to Go

Both N95 and KN95 masks can’t be reused forever, so you’ll have to know when it’s time to toss it. There is no hard-and-fast deadline—the masks’ effectiveness declines over time—but experts say if the mask is visibly dirty or damaged, stained, or gets damp, it’s time to let it go.

Any time someone comes in close contact with an individual infected with Covid-19, they should opt for a new N95 or KN95 face mask.

 -Corryn Wetzel, Smithsonian Magazine



Friday, January 14, 2022

Proper Fit and Use of N-95 Masks

 


Proper N95 Respirator Use for Respiratory Protection Preparedness

Posted on by Maryann M. D’Alessandro, PhD, and Jaclyn Krah Cichowicz, MA

When outbreaks of infectious disease occur, we rely on healthcare professionals to care for those affected, putting themselves at increased risk of exposure to the pathogen causing the disease. While engineering and administrative controls should be the first considerations to protect these workers from this exposure, facilities should also ensure that at-risk employees are prepared to use respiratory protection, among other personal protective equipment, should the need arise.

To aid healthcare facilities experiencing shortages of N95 respirators due to high demand across the nation, CDC developed the Strategies for Optimizing the Supply of N95 Respirators in Healthcare Settings which provides options on how to optimize supplies of disposable N95 filtering facepiece respirators (commonly called “N95 respirators”) in healthcare settings when there is limited supply. CDC prioritizes respirator use for healthcare personnel in close contact with (i.e., within 6 feet of) patients with suspected or confirmed coronavirus disease (COVID-19), during aerosol generating procedures, and for infectious diseases when airborne precautions should be followed. These activities include patient assessment for triage, entering examination rooms or patient rooms to provide care or to clean and disinfect the environment, entering a patient’s home, obtaining clinical specimens, and handling soiled medical supplies or equipment.

However, preparedness is crucial during outbreaks of disease; healthcare workers who may be called to care for COVID-19 patients, should the need arise in the future, should be fit tested if possible, medically evaluated, and training should be ongoing. To aid with these preparedness efforts, here are some reminders about proper respirator selection and use.

Filtration, Fit, and Proper Use

Three key criteria are required for a respirator to be effective:

1.The respirator filter needs to be highly effective at capturing particles that pass through it,

2.The respirator must fit the user’s face snugly (i.e., create a seal) to minimize the number of particles that bypass the filter through gaps between the user’s skin and the respirator seal; and

3.The respirator must be put on (donned) and taken off (doffed) correctly before and worn throughout the exposure.

(Link to infographic on the Key Factors of Respiratory Protection)

OSHA requires healthcare workers who are expected to perform patient activities with those suspected or confirmed to be infected with COVID-19 to wear respiratory protection, such as an N95 respirator. N95 respirator refers to an N95 filtering facepiece respirator (FFR) that seals to the face and uses a filter to remove at least 95% of airborne particles from the user’s breathing air. NIOSH also approves other FFRs that are as, or more, protective as the N95, including the N99, N100, P95, P100, R95, and R100. It is important to note that surgical masks, sometimes referred to as facemasks, are different than respirators and are not designed nor approved to provide protection against airborne particlesSurgical masks are designed to provide barrier protection against droplets, however they are not regulated for particulate filtration efficiency and they do not form an adequate seal to the wearer’s face to be relied upon for respiratory protection. Without an adequate seal, air and small particles leak around the edges of the respirator and into the wearer’s breathing zone.

When properly fitted and worn, minimal leakage occurs around the edges of an N95 respirator when the user inhales, ensuring that the user’s breathing air is being directed through the filter material. Staff that are required to use respiratory protection must undergo fit testing, medical clearance, and training, which are all required elements of a healthcare facility’s written respiratory protection program. These are requirements of the Occupational Safety and Health Administration (OSHA) Respiratory Protection standard (29 CFR 1910.134).

Fit testing is a critical component to a respiratory protection program whenever workers use tight-fitting respirators. OSHA requires an initial respirator fit test to identify the right model, style, and size respirator for each worker. Annual fit tests ensure that users continue to receive the expected level of protection. A fit test confirms that a respirator correctly fits the user. Additionally, tight-fitting respirators, including N95s, require a user seal check each time you put one on to help ensure the best fit possible. In the US, NIOSH-approved respirators include instructions on how to conduct a user seal check.

During times of extreme supply constraints, when there may be limited availability of respirators or fit test kits, employers may face challenges in fit testing workers. Employers should make every effort to ensure that workers who need to use tight-fitting respirators are fit tested to identify the right respirator for each worker.

Fit Under Fire: Situational Strategies to Achieve the Best Respirator Fit During Crisis

Under serious outbreak conditions in which respirator supplies are severely limited, however, you may not have the opportunity to be fit tested on a respirator before you need to use it. While this is not ideal, in this scenario, you should work with your employer to choose the respirator that fits you best, as, even without fit testing, a respirator will provide better protection than a facemask or using no respirator at all. If possible, start with the size you have been fit tested for previously, but as size can vary by manufacturer and model, you may need to wear a different size to achieve a good fit. (If you have never been fit tested before, the following recommendations are still useful.) The respirator should fit over your nose and under your chin. If you cannot get a good face seal, try a different model or size. If you receive respirators, and you need to use them right away without fit testing, ask your employer for additional (you should have already received training on proper respirator use and user seal checks) product training videos and literature on proper donning and doffing, which should be available from the manufacturer. Practice putting on the respirator and doing a user seal check at least several times. Check the fit in a mirror or ask a colleague to look to be sure the respirator is touching your face and appears to be on properly. While fit testing is ideal to confirm if a respirator does or does not fit, healthcare professionals should be able to obtain a good fit if they have had training and they perform a user seal check prior to each use of the respirator.

Even if workers begin using respirators without proper fit testing, employers should make every effort to perform fit testing as respirator supplies allow. Employers should always perform fit testing for workers who cannot successfully seal check their own respirators.

In addition to a user seal check, properly donning the respirator in the first place will help to achieve a good fit. Here are some additional considerations when donning your respirator:

 

 

  1. Place the respirator over your nose and under your chin. If the respirator has two straps, place one strap below the ears and one strap above. If you’re wearing a hat, it should go over the straps.
  2. If the respirator has a noseclip (a thin metal bar at the top of the device), use your fingertips from both hands to mold the noseclip firmly against your nose and face. Do not pinch with one hand.
  3. Be sure to conduct a user seal check every time you put on the respirator. This should be done before you enter a patient room. Your respirator may have instructions on how to conduct a user seal check.
  4. Facial hair will cause the respirator to leak, so users should be clean-shaven. Some types of facial hair are acceptable as long as the facial hair does not lie along the sealing area of the respirator.
  5. If you feel dizzy, lightheaded, or nauseated, leave the patient room, remove your respirator, and get medical attention.
  6. Discard the respirator when: (1) it becomes more difficult to breathe through it, (2) if it becomes dirty or (3) the respirator becomes damaged.
  7. Do NOT TOUCH the front of the respirator! It may be contaminated.
  8. Keep your respirator clean and dry. Be sure to read and follow the manufacturer’s recommendations on use and storage.
  9. If supplies are short, facilities should consider applying the appropriate strategies identified in the CDC Strategies for Optimizing the Supply of N95 Respirators.

 

You can find additional information on how to protect healthcare workers in times of outbreak by regularly visiting the CDC’s Coronavirus information for Healthcare Professionals webpage.

Maryann M. D’Alessandro, PhD, is the Director of the NIOSH National Personal Protective Technology Laboratory

Jaclyn Krah Cichowicz, MA, is a Health Communications Specialist in the in the NIOSH National Personal Protective Technology Laboratory.

 

Other Resources

Proper Use, Filtration, and Fit – The Three-Legged Stool of Respiratory Protection (Blog)

Required Labeling of a NIOSH-Approved N95 Filtering Facepiece Respirator Infographic

Key Factors of Respiratory Protection Infographic

NIOSH Respirator Filter Classes Infographic

A Particle is a Particle (Video)

N95 Respirators and Surgical Masks (Blog)

Understanding the Difference: Surgical Masks and N95 Respirators Infographic

How to Properly Put on or Take off a Disposable Respirator (Instruction sheet)

Hospital Respiratory Protection Program Toolkit

Filtering out Confusion: Fit Testing (Fact Sheet)

Filtering out Confusion: User Seal Check (Fact Sheet)

Donning, Doffing, and User Seal Checks (Video)

To Beard or not to Beard, That’s a Good Question (Blog)

CDC’s Strategies for Optimizing the Supply of N95 Respirators



Thursday, January 13, 2022

Tips to Spot N95 & KN95 Counterfeit Respirators (CDC)

 

Counterfeit Respirators / Misrepresentation of NIOSH-Approval

Notice on NIOSH ownership of respirator certification marks

NIOSH has successfully recorded the NIOSH stylized logo with and without text, as well as the certification marks N95, N99, N100, P95, P100, and the term “NIOSH-approved”, with the U.S. Patent and Trademark Office (USPTO). NIOSH, as the certifying federal entity for the N95 Respirator Approval Program, owns these certification marks, meaning that NIOSH controls who can use these marks. Accordingly, NIOSH will let manufacturers use these certification marks only if they become NIOSH-approval holders because of their products satisfying the NIOSH’s regulatory standards set forth in 42 C.F.R. Part 84. While these marks have historically been protected under common law (as opposed to a trademark registration) since they were established by the program regulations, these marks are now registered with the USPTO as federal registrations, as well as in various foreign countries, and are subject to additional protections under the Lanham Act, 15 U.S.C. §§ 1051 et seq. and foreign trademark laws. Thus, any misuse of these marks, including on respirators that have failed to satisfy NIOSH’s regulatory requirements or have not received a NIOSH approval, is a direct violation of applicable trademark laws and NIOSH may pursue action as necessary. This also applies to approval holders that misuse or misplace the marks or terms against the regulations, specifically outlined in 42 C.F.R. Part 84.33.

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:

  • 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

Check the respirator approval markings using the Example of Correct Exterior Markings on a NIOSH-Approved Filtering Facepiece Respirator graphic.

More Tips to Spot Counterfeit Respirators

Note – Below the most recent listings are additional counterfeit respirators.

The Health Protective KN95 mask is being marketed as “Certified KN95 respirator mask, adopted by the CDC”.  This statement is misleading because CDC, through NIOSH, does not approve KN95 masks or any other respiratory protective device certified to international standards.

The Health Protective KN95 mask is being marketed as “Certified KN95 respirator mask, adopted by the CDC”. This statement is misleading because CDC, through NIOSH, does not approve KN95 masks or any other respiratory protective device certified to international standards. Additionally, Health Protective is misusing NIOSH test information. The product package indicates it meets Chinese standard GB 2626-2006 and was submitted to NIOSH under an International Respirator Assessment request. It is being marketed using results from the assessment. As stated on the NIOSH website, these results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers and cannot be used to make claims that the product meets NIOSH approval requirements. Changshu City Hengyun Nonwoven Products Co., Ltd. is not a NIOSH approval holder or a private label holder. (1/11/2022)

Guangzhou Zhen Tao Culture Media Co., Ltd. is marketing Benehal Model 8865 as a NIOSH approved unit for kids.  NIOSH does not approve filtering facepiece respirators for children.

Guangzhou Zhen Tao Culture Media Co., Ltd. is marketing Benehal Model 8865 as a NIOSH approved unit for kids. NIOSH does not approve filtering facepiece respirators for children. Although Suzhou Sanical Protective Product Manufacturing Co. Ltd. manufactures Benehal Model 8865, under NIOSH approval number TC-84A-7449, this unit is not NIOSH approved as a filtering facepiece respirator for children. (12/17/2021)

This is an example of a misrepresentation of NIOSH approval. SafeShield’s marketing of model FS-N95 is misleading and may cause users to believe it is NIOSH approved.

This is an example of a misrepresentation of NIOSH approval. SafeShield’s marketing of model FS-N95 is misleading and may cause users to believe it is NIOSH approved. SafeShield references certification to NIOSH CFR 42.84 180-181 and TEB-APR-STP-0059. This information is inaccurate. SafeShield is not a NIOSH approval holder or private label assignee, and model FS-N95 is NOT NIOSH approved. (12/1/2021)

This is an example of a misrepresentation of a NIOSH approval. Megha International is marketing the Feel Safe Mask N95 in a package marked NIOSH Certification.

This is an example of a misrepresentation of a NIOSH approval. Megha International is marketing the Feel Safe Mask N95 in a package marked NIOSH Certification. Megha International is not a NIOSH approval holder or private label assignee. Feel Safe Mask N95 is NOT NIOSH approved. (11/5/2021)

Dongguan AOXING is misusing NIOSH test information for its KN95 Protective Mask model AX-KF95.

Dongguan AOXING is misusing NIOSH test information for its KN95 Protective Mask model AX-KF95. Product was submitted to NIOSH under an International Respirator Assessment request and it is being marketed using results from the assessment. As stated on the NIOSH website, these results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers and cannot be used to make claims that the product meets NIOSH approval requirements. Dongguan AOXING is not a NIOSH approval holder or a private label assignee. (11/5/2021)

This is an example of a misrepresentation of a NIOSH approval. AP Mascarillas is not a NIOSH approval holder or private label assignee. AP Mascarillas is marketing product using the NIOSH logo, but their respiratory protective devices are NOT NIOSH approved.

This is an example of a misrepresentation of a NIOSH approval. AP Mascarillas is not a NIOSH approval holder or private label assignee. AP Mascarillas is marketing product using the NIOSH logo, but their respiratory protective devices are NOT NIOSH approved. (9/9/2021)

This is an example of a misrepresentation of a NIOSH approval. Sobmex is marketing numerous filtering facepiece respirators with NIOSH listed on the technical specifications sheet, but Sobmex is not a NIOSH approval holder or private label assignee. Sobmex respirators are NOT NIOSH approved.

This is an example of a misrepresentation of a NIOSH approval. Sobmex is marketing numerous filtering facepiece respirators with NIOSH listed on the technical specifications sheet, but Sobmex is not a NIOSH approval holder or private label assignee. Sobmex respirators are NOT NIOSH approved. (9/9/2021)

Moaron is NOT a NIOSH approval holder and they are misrepresenting product as meeting NIOSH approval.

Moaron is NOT a NIOSH approval holder and they are misrepresenting product as meeting NIOSH approval. The product listing claims the filter “meets NIOSH P100-series.” NIOSH only approves whole respirator configurations, not individual components. The Moaron 2091 P100 filter is NOT a component associated with a NIOSH approval. Additionally, it is incorrectly being advertised that it is compatible with other NIOSH-approved products. If this filter is used in place of the filter component associated with the NIOSH-approved respiratory protective device (RPD), it will void the NIOSH approval. (9/9/2021)

This is an example of a misrepresentation of a NIOSH approval. Pure&Safe is not a NIOSH approval holder or a private label assignee.  The Pure&Safe 5 Layered Reusable Anti-Pollution N95 Face Mask with Activated Carbon Filter is not NIOSH approved.

This is an example of a misrepresentation of a NIOSH approval. Pure&Safe is not a NIOSH approval holder or a private label assignee. The Pure&Safe 5 Layered Reusable Anti-Pollution N95 Face Mask with Activated Carbon Filter is not NIOSH approved. (5/26/2021)

This is an example of a misrepresentation of a NIOSH approval. U-SAFE is not a NIOSH approval holder or a private label assignee. U-SAFE models B120 and B130 N95 particulate respirator are not NIOSH approved.

This is an example of a misrepresentation of a NIOSH approval. U-SAFE is not a NIOSH approval holder or a private label assignee. U-SAFE models B120 and B130 N95 particulate respirator are not NIOSH approved. (4/30/2021)

This is an example of a misrepresentation of a NIOSH approval. Osprey is not a NIOSH approval holder or a private label assignee. The Osprey N95 particulate respirator is not NIOSH approved.

This is an example of a misrepresentation of a NIOSH approval. Osprey is not a NIOSH approval holder or a private label assignee. The Osprey N95 particulate respirator is not NIOSH approved. (4/21/2021)

EPC Product, LLC is misrepresenting product manufactured by their company as NIOSH-approved product.  Models sold by EPC, including but not limited to, PT-N95F-01, PT-N95C-02, and PT-N95CS-02 are NOT NIOSH-approved.  EPC Product LLC is not a NIOSH approval holder or a private label holder.

EPC Product, LLC is misrepresenting product manufactured by their company as NIOSH-approved product. Models sold by EPC, including but not limited to, PT-N95F-01, PT-N95C-02, and PT-N95CS-02 are NOT NIOSH-approved. EPC Product, LLC is not a NIOSH approval holder or a private label holder. (3/26/2021)

SS Paper Convertors is misrepresenting protective masks as NIOSH-approved.  SS Paper Convertors is not a NIOSH approval holder or private label holder.  La’ Forte brand masks are not NIOSH-approved.

SS Paper Convertors is misrepresenting protective masks as NIOSH-approved. SS Paper Convertors is not a NIOSH approval holder or private label holder. La’ Forte brand masks are not NIOSH-approved. (2/26/2021)

Zhengzhou Ruipu Medical Technology Co., Ltd. is misusing NIOSH test information regarding RUIPU RIPE DOCTORS KN95.

Zhengzhou Ruipu Medical Technology Co., Ltd. is misusing NIOSH test information regarding RUIPU RIPE DOCTORS KN95. The product package indicates it meets Chinese standard GB 2626-2006 and was submitted to NIOSH under an International Respirator Assessment request. It is being marketed using results from the assessment. As stated on the NIOSH website, these results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers and cannot be used to make claims that the product meets NIOSH approval requirements. Zhengzhou Ruipu Medical Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. (2/18/2021)

Chengde Technology Co., Ltd. is misusing NIOSH test information regarding WWDOLL model CD9501B KN95 Foldable Protective Masks.

Chengde Technology Co., Ltd. is misusing NIOSH test information regarding WWDOLL model CD9501B KN95 Foldable Protective Masks. The product package indicates it meets Chinese standard GB 2626-2019 and was submitted to NIOSH under an International Respirator Assessment request. It is being marketed using results from the assessment. As stated on the NIOSH website, these results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers and cannot be used to make claims that the product meets NIOSH approval requirements. Chengde Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. (2/18/2021)

Raxwell model RX9501P N95 is being misrepresented as a NIOSH-approved product.

Raxwell Industrial Technology Co., Ltd. is misusing NIOSH test information regarding Raxwell model RX9501 KN95 Face Masks. The product package indicates it meets Chinese standard GB 2626-2006 and was submitted to NIOSH under an International Respirator Assessment request. It is being marketed using results from the assessment. As stated on the NIOSH website, these results are not to be used by manufacturers, distributors, suppliers, and importers to make claims about their products and/or to influence purchasers and cannot be used to make claims that the product meets NIOSH approval requirements. Additionally, Raxwell model RX9501P N95 is being misrepresented as a NIOSH-approved product. Raxwell Industrial Technology Co., Ltd. is not a NIOSH approval holder or a private label holder. (2/18/2021)

This is an example of a misrepresentation of a NIOSH-approved product. Products labeled TENAMYD FM and sold by Clean Life 360 are NOT NIOSH approved.  (2/4/2021)

This is an example of a misrepresentation of a NIOSH-approved product. Products labeled TENAMYD FM and sold by Clean Life 360 are NOT NIOSH approved. (2/4/2021)