Yes. The FDA of US is working diligently to mitigate any potential shortages in the supply chain and taking action to assure health care personnel on the front lines have sufficient supplies of respiratory protective devices. The FDA concluded, based on the totality of scientific evidence available, that certain imported respirators that are not NIOSH-approved are appropriate to protect the public health or safety.
On March 24, 2020, the FDA issued an Emergency Use Authorization (EUA) for importing non-NIOSH-approved N95 respirators. Under this EUA, among other criteria, the FDA accepts marketing authorization from Australia, Brazil, Europe, Japan, Korea, and Mexico who have similar standards to NIOSH. The FDA did not list KN95 respirators in this EUA because of concerns about fraudulent products listed as KN95s. On April 3, 2020, in response to continued respirator shortages, the FDA issued a new EUA for non-NIOSH-approved N95 respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator meets certain standards.
The FDA also issued guidance outlining a policy to help expand the availability of general use face masks for the general public and respirators for health care professionals during this pandemic. The guidance applies to KN95 respirators as well. It explains that for the duration of the pandemic, when FDA-cleared or NIOSH-approved N95 respirators are not available, the FDA generally would not object to the importation and use of respirators without an EUA, including KN95 respirators. Although not required, if a KN95 respirator does not have an EUA, the FDA encourages importers to take the appropriate steps to verify the product’s authenticity prior to importing.
And Yes, the NVW supplied KN95 are all in EUA.
The FDA of US recognizes that the need by healthcare providers and personnel for personal protective equipment (PPE) such as surgical masks and surgical and isolation gowns, may outpace the supply during the Coronavirus Disease 2019 (COVID-19) outbreak.
The FDA is collaborating with manufacturers of personal protective equipment (PPE) to help facilitate mitigation strategies related to the COVID-19 outbreak. The FDA’s door is open, and we are available to collaborate with stakeholders.
To help alleviate supply pressures, the FDA may consider expedited review of manufacturing site changes or premarket submissions—manufacturers of PPE (particularly surgical masks and surgical or isolation gowns) may contact FDA regarding plans to increase availability of these products to the U.S. market.
For reference, the applicable product codes discussed in these FAQs are:
- Surgical masks (FXX)
- Surgical mask with antimicrobial/antiviral agent (OUK)
- Pediatric/child facemask (OXZ)
- Surgical gowns (FYA)
- Isolation gowns and surgical apparel accessories (FYC, LYU, OEA)
- Surgical suits (FXO)
- Surgical masks are intended to provide broad barrier protection. In US, at this time, FDA has not cleared, approved, or authorized any surgical masks for specific protection or prevention against the virus that causes COVID-19. But with the experience of china, Surgical mask, or Medical mask, or even disposable face mask, could have good performance to sharp reduce the possibility of spreading COVID-19 in crown while people also keep social distancing. As the virus that causes COVID-19 is mainly spread by Droplets and aerosols, Wear Surgical mask can reduce the chance that the Contaminated hand touch nose and mouth.
- Wear the face mask is for protecting healthy people! As COVID-19 mainly causes patients to have difficulty breathing, and then, hold on mask on their face will be more hard.
The CDC recommends that members of the public use simple cloth face coverings when in a public setting to slow the spread of the virus, since this will help people who may have the virus and do not know it from transmitting it to others.
The best way to prevent illness is to avoid being exposed to this virus. However, as a reminder, the CDC always recommends everyday preventive actions, such as hand washing and maintaining at least 6 feet of social distancing, to help prevent the spread of respiratory diseases.
Social distancing, also called “physical distancing,” means keeping space between yourself and other people outside of your home. To practice social or physical distancing:
- Stay at least 6 feet (2 meters) from other people
- Do not gather in groups
- Stay out of crowded places and avoid mass gatherings
In addition to everyday steps to prevent COVID-19, keeping space between you and others is one of the best tools we have to avoid being exposed to this virus and slowing its spread locally and across the country and world.
When COVID-19 is spreading in your area, everyone should limit close contact with individuals outside your household in indoor and outdoor spaces. Since people can spread the virus before they know they are sick, it is important to stay away from others when possible, even if you have no symptoms. Social distancing is especially important for people who are at higher risk of getting very sick.
- There is currently no vaccine to prevent coronavirus disease 2019 (COVID-19).
- The best way to prevent illness is to avoid being exposed to this virus.
- The virus is thought to spread mainly from person-to-person.
- Between people who are in close contact with one another (within about 6 feet).
- Through respiratory droplets produced when an infected person coughs, sneezes or talks.
- These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.
- Some recent studies have suggested that COVID-19 may be spread by people who are not showing symptoms.
Clean your hands often
- Wash your handsoften with soap and water for at least 20 seconds especially after you have been in a public place, or after blowing your nose, coughing, or sneezing.
- If soap and water are not readily available, use a hand sanitizer that contains at least 60% alcohol. Cover all surfaces of your hands and rub them together until they feel dry.
- Avoid touchingyour eyes, nose, and mouth with unwashed hands.
Cover coughs and sneezes
- If you are in a private setting and do not have on your cloth face covering, remember to always cover your mouth and nosewith a tissue when you cough or sneeze or use the inside of your elbow.
- Throw used tissuesin the trash.
- Immediately wash your handswith soap and water for at least 20 seconds. If soap and water are not readily available, clean your hands with a hand sanitizer that contains at least 60% alcohol.
Clean and disinfect
- Clean AND disinfect frequently touched surfacesdaily. This includes tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
- If surfaces are dirty, clean them:Use detergent or soap and water prior to disinfection.
- Wear the gloves, such as PVC gloves, or Nitrile gloves when work.
- Alcohol solutions.
Ensure solution has at least 70% alcohol.