Clear as Mud? Understanding the KN-95 Suspension by FDA

Clear as Mud? Understanding the KN-95 Suspension by FDA Image

by Olivia Wann, BS, JD

There is much confusion over FDA suspending the Emergency Use Authorization on KN95s. Keep in mind that the Chinese version of N95s do not meet US standards.

Since supplies of N95s are readily available, we can no longer use the KN95s. They are not NIOSH-approved. Even if the Emergency Temporary Standard (ETS) does not apply because dental offices are not hospital-based, they are screening all non-employees for COVID symptoms and they prohibiting seeing suspicious COVID or confirmed COVID, they still come under CDC’s guidance.

Unfortunately we are still under the Dec 4th guidance. This is due to change any day. Respirators are recommended for aerosol generating procedures (AGP). We hope to see more defined guidance from CDC soon because OSHA uses it for dental inspections and for the National Emphasis Program (NEP). From my experience with OSHA complaints, unless there are engineering controls in place to prove the aerosol hazard does not exist, OSHA will look closely at masks. If a respirator is warranted, it should be NIOSH-approved.

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