KN95 Face Mask FDA Whitelist

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KN95 Masks Appendix A Whitelist Designed with 5 Layers of Protective Filtration - Tested By NPPTL.

Are you looking for an N95 Face Mask? We have a limited supply of Harley and Makrite N95 respirators available. Click Here

New - Our KN95 face masks meet or exceed the CN Standard standard GB2626-2006 . Our KN95 masks have a multi-layer design for protection (PPE face masks for filtering particulate, viruses, and microbes). Our KN95 Face Mask is certified to standards similar to the EU FFP2 certification and the US N95 approved mask. 

Update: In the 2nd half of 2020, the FDA changed their emergency use rules for medical and healthcare professionals. This rule change affected all KN95 masks. This update was in response to the increase in the availability of N95 respirators. KN95 masks continue to provide excellent protection and value for business and personal use. 

Omicron Variant and Face Mask Recommendations

The Centers for Disease Control and Prevention on Friday, Jan. 14, updated its "Types and Masks and Respirators" page to specify that "loosely woven cloth products" offer the least amount of protection, followed by "layered finely woven products." Surgical masks and KN95s provide "even more protection," while approved respirators, like N95s, offer the most. The agency recommends wearing "the most protective mask you can that fits well and that you will wear consistently." 

The decision comes as many health experts have urged the public to switch to higher-quality masks, like N95s or KN95s, as the omicron coronavirus variant — which transmits and evades COVID-19 vaccines more easily — rapidly spreads throughout the United States.

Read more on new guidelines.

About KN95 Face Masks

Designed for comfort and ease of use with flexible elastic ear loops and an integrated, flexible nose bridge to help ensure proper fit. The KN95 standard means these masks are effective against 95 percent of particles with a diameter of 0.3 microns or larger. Properly worn masks can protect against PM10, PM2.5, and smaller particles. BFE>95% (Bacterial filtration efficiency) 

5-Ply Layers of Protective Filtration – Our KN95 mask is genuinely made of 5 layers with two non-woven outer layers as well as two melt-blown inner layers and a non-woven middle layer to absorb small moisture particles. These masks offer superior protection to a cloth face mask or standard 3-ply disposable mask. 

Quality You Can Trust

Tested By NPPTL (National Personal Protective Technology Laboratory) on Jun. 19, 2020, with a Minimum Filter Efficiency of 99.81 and Maximum Filter Efficiency of 99.90, which can help protect you and the ones around you in every situation, be it travel, shopping, working out, commuting or being out at the park. Multi-layered protection against dust, particles, and droplets. Filter efficiency 99.3% to 97.19%

KN95 vs Surgical Face Mask: What is the difference?

  • A KN95 respirator is a respiratory protective device designed to achieve a very close facial fit and efficiently filter out airborne particles. Note that the edges of the respirator form a seal around the nose and mouth.
  • Surgical Mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Surgical masks are made in different thicknesses and with different abilities to protect you from contact with liquids. A surgical mask may effectively block splashes and large-particle droplets; a face mask, by design, does not filter or block tiny particles in the air transmitted by coughs, sneezes, or specific medical procedures. 
  • Want to learn more about the difference between KN95 and Surgical Face Mask? Read our Blog

N95 vs. KN95 Mask: What is the difference?

  • Based on this comparison by 3M, it is reasonable to consider China KN95, AS/NZ P2, Korea 1st Class, and Japan DS2 FFRs as "similar" to US NIOSH N95 and European FFP2 respirators, for filtering non-oil-based particles such as those resulting from wildfires, PM 2.5 air pollution, volcanic eruptions, or bioaerosols (e.g., viruses). 
  • Both ratings require masks to be tested for filtration efficiency at capturing salt particles (NaCl). Both have been tested at a flow rate of 85 L/minute.
  • N95s and KN95s are both rated to capture 95% of particles. Among the minor differences, only KN95 masks are required to pass fit tests, while N95 masks have slightly stronger breathability standards.
  • Bottom Line: For everyday use, KN95 masks are an excellent value. FDA White list KN95 may be used by HCP when N95 masks are not available. 

Medical Grade Materials • Highly Efficient Filtration • Optimal Comfort  

A KN95 Face Mask can help reduce exposure to biological substances, such as bacteria and viruses. However, wearing a mask will not eliminate the risk of infection. It depends on the proper fit of the mask for the wearer. 

A study published in 2008 showed that face masks were up to 80% effective in reducing transmission and infection from airborne viruses. Link Here

  • Environmental - The KN95 Face Mask can protect you from smoke, pollen, and pollution. The filter has an efficiency of above 95% at 0.3 pm particle size; ordinary pollen particles are about 10 - 1000 pm in size.
  • Animal Allergens - The KN95 Face Mask can protect you from animal allergens. The KN95 Face Mask has an efficiency of above 95% at 0.3 pm particle size, and animal allergen particles are about 5 - 10 pm in size.
  • Due to Health Regulations, we cannot accept returns on this Item.

More Information: 

  • NEW - Meets or exceeds CN Standard GB2626-2019 for better breathability. Filter at least 95% of airborne particles .3 microns or larger
  • This is a KN95 mask, NOT an N95 Respirator.
  • Manufactured in an FDA Registered facility
  • Click here to view 3M's Technical Specifications for KN95 and N95
  • The KN95 standard means that the mask provides the intended effectiveness of filtering 95 percent of particles with a mass median diameter of 0.3 microns. 


  • This mask does not eliminate the risk of contracting any disease or infection. Immediately change your mask if it becomes soiled with blood or body fluid.

Please Note:

  • Due to safety concerns, personal protective equipment, including face masks, is NON-returnable.   
  • Filtering facepiece respirators ("FFRs") are intended for single usage. Reuse of FFRs is not generally recommended, and disposable FFRs have not been approved for routine decontamination. The decision to permit extended use or limited reuse of FFRs should be made in consultation with federal, state, and local public health recommendations and occupational health or infection control professionals. See Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings, CDC, (last updated Mar. 27, 2020); Decontamination & Reuse, CDC, (last updated Apr. 29, 2020).]



Frequently Asked Questions

How can you tell if your KN95 is real?

The easiest way to tell if your KN95 mask is authentic is by using the water test. If you can pour water into the face of the mask and it does not leak, your KN95 mask is real.

What is the Water Resistance Test?

As we mentioned, the water test is a way to test your KN95 mask to ensure it is authentic. To perform the water test, hold the mask carefully as you slowly pour water into the face of the mask. If your mask does not let any water through, it is an authentic KN95 mask. You can watch our video here demonstrating the authenticity of our KN95 masks.

What is the difference between the KN95 and N95?

The N95 and KN95 masks have many similarities. Most importantly, they both effectively filter out 95% of particles. The main difference between the two is that the N95 is tested to meet the US standards for safety, whereas the KN95 are tested to meet international standards. If you would like to learn more about the difference in face masks, you can watch our informational video here or read more about the different masks here.

Can you wash your face mask?

No, all of our face masks are meant for single use and should not be washed. However, they can be reused for up to 8 hours of total use.

Is the KN95 medical grade?

Similar to KN95 face masks, most N95 masks are not made for 'medical' use. Instead, they are generally used for industrial purposes. Typically, N95 masks are preferred by the FDA and CDC for viral protection due to their more secure and tighter fit around the nose and the mouth.

A medical mask is defined by its ability to resist fluid splatter. Only a few N95 masks are actually considered to be medical grade, such as the 3M 1869 masks. Due to a shortage of medical N95 masks during the COVID 19 pandemic, the FDA released an approved list of KN95 masks to be used in emergency medical settings. You can find approved KN95 masks here.

Why are 3 Ply and KN95 masks melt-blown instead of stitched to combine the layers?

The different layers of the 3-Ply and KN95 masks are binded using the meltdown method as it allows the layers to remain separate, providing more efficient filtration. This is why you may notice what may appear to be holes around the KN95. These are not actually holes, they are the areas where the 5 layers of the mask have been bonded together.