KN95 L-103V - FDA cleared for all general use under EUA Appendix A.
We have been approved since the start of the EUA!
Most KN95s found in the market are not approved by the FDA as respirators. If you are purchasing respirators for your protection, please check if they are on the FDA's EUA list as approved.
The Harley L-103V KN95 is made by a NIOSH certified manufacturer and is on the FDA EUA approved list. Be aware of some competitors that are not listed on the list are falsely claiming FDA approval.
Being a true respirator, we are particularly recommending the use of this device for,
When you want to protect both yourself and others, a good respirator is what you need.
How do you know if your respirator actually works? The answer is if it has been thoroughly scrutinized by the FDA.
Our KN95 being approved by the FDA, is as good a protection as the public can get and not completely break the bank.
This certified respirator is perfect for isolating your breathing from the environment - dust or pathogens. Unlike loose face masks or surgical mask, a respirator, especially a KN95, is tested to strict leaking requirements. Without leaks, the air is effectively filtered.
Also unlike typical flat masks, these fold-able respirators can be worn longer and since there is no contact between your mouth and the mask, less moisture is retained, all this helps to not affect our speech.
As shown in studies, a good fit is essential to effective protection for the wearer and others around. Basically, the tighter the better especially at the nose bridge and cheeks.
Perfect for longer wear, better protection, and reduced speech disruption. We highly recommend these for,
public transportation commuters
or any other situations where you are indoors and unable to keep proper social distancing
There are a lot of KN95s in the market at various price-points but only very few are actually on the FDA list as approved for all use use and accepted as equivalent. Even fewer are made by NIOSH certified manufacturers. The biggest differences between a quality KN95 (like ours) and a typical KN95 are,
Consistent production quality
Comfort (Relative to respirators which are normally uncomfortable)
There are currently massive amounts of KN95s being dumped into the market. The reason for this is when the FDA and CDC created the short approved list, the gross overproduction by inept manufacturers was left without buyers from the healthcare sector and public (those with knowledge of this) sector. This has caused prices of these KN95s to drop. Be wary of these!
 Please note,
If you are a heathcare professional, there have been studies that the SARS-CoV-2 can actually be airborne particularly in areas around patients. There has been a very noticeable number of cases where staff wearing surgical masks get infected.
Based on this, we highly recommend that medical staff that are within eye-shot of patients, wear respirators. If you are not issued respirators and are allowed to provide your own, we will help one way or another. Let us know.
 Another note,
Due to the high number of KN95 manufacturers, the FDA back in early April, reviewed and approved a relatively short list of approved manufacturers. Then the CDC's National Personal Protection Testing Laboratory (NPPTL) released an evaluation (April 30, 2020) of an even shorter list of approved manufacturers and tested 10 samples each for the particulate filtration efficiency (PFE) that is benched mark at > 95% of 0.1 micron.
The results were astounding!
More than 60% of the 67 tested had minimums that didn't achieve the 95% PFE. This shows manufacturing inconsistencies. As a result, the FDA has dropped most manufacturers from being cleared as equivalents to the N95 for medical use. The staple manufacturers that have been left on the list are primarily NIOSH certified manufacturers (Ours is a NIOSH certified producer).
The good news is, we are well above the 95%, in fact, no less than 99% of 0.1 micron. Rest assured!
However, as the NPPTL mentioned, all mask performance are dependent on the proper wearing of the masks. So follow the instructions.
Here is the link to the FDA approved KN95s for use. Please note that our manufacturer is Guangzhou Harley model L-103V.
Guangzhou Harley is a NIOSH certified manufacturer in China. For those concerned about these products from China, please see why we chose them for this product here.
Currently, our KN95 L-103V (FDA cleared for medical and public) respirators are sold in minimum of 20 pieces per order. Additional bulk discounts are available.
In stock and shipping from the USA
**Please know that respirators are meant to be tight when worn. This is to ensure that there is a good seal around the face for maximum filtration. To some, this may get uncomfortable or take some getting used to. We recommend the nose clip be spread wider before wearing the mask; this helps with comfort, especially since it is quite stiff in order to maintain the shape of the mask when worn. Remember, a loose respirator is not an effective respirator.**
Performance vs. comfort
Respirators, including KN95s, N95s, or any other FFR (Filtering Facepiece Respirators), need to form a tight seal on the wearer's face to filter effectively.
The problem is that different cuttings and designs may work better than others as far as sealing and being less uncomfortable.
One way to maximize sealing and comfort is to have more space between the start of the straps to the edge of the mask. This space becomes the soft gasket and having fewer pressure points.
Below here are two other KN95s (Brand "S" and "N") that we have compared to the L-103V. The reason why not all manufacturers just go with the more space between the strap weld points and the edge is cost. The mask will have to be bigger, which makes it more costly to produce.
A comparison between two other brands with our L-103V
On BRAND "S",
notice that there is only 10mm from where the strap is welded to the edge of the mask.
On BRAND "N",
there is 14mm from where the strap is welded to the edge of the mask.
On our KN95, we do better by adding more for comfort and seal!
19mm from where the strap is welded to the edge of the mask.
For those who may find the KN95s too tight or those who wear them for hours at a time, the back of the ears gets sore. There are "ear-savers" that are sold by others, but an idea a staff of ours came up with is using the cotton gauze used for makeup removal and stapling them around the straps. We tried it, and this works great!
Give it a try.