Spectrum Statement 

SM335 - KN95

Spectrum adheres to the following guidelines

  • Spectrum continues to follow FDA importer guidelines

  • Our manufacturer is Registered with FDA

  • Our SM335 KN95 is a certified CE EN-149 FFP2

  • Products are designed to meet the standards of GB2626-2006; EN149:2001+A1:2009


Here at Spectrum, we endeavor to be as transparent as possible and will continue to do so. Our SM335 KN95 Mask has been authorized by FDA under an EUA for use by HCP as PPE to help prevent the spread of infection or illness in healthcare settings and by the general public to help slow the spread of the virus during the COVID-19 pandemic.  


Although Spectrum's SM335 KN95 mask meets the eligible criteria for emergency use in a healthcare environment, out of an overabundance of caution, we continue to advertise they are not  recommended for use in a surgical setting or where significant exposure to liquid, bodily or other hazardous fluids may be expected and where the infection risk level through inhalation exposure is high .


We defer use of these products in a healthcare environment to the 
individual  discretion of each purchaser. We continue to gather information from our suppliers and testing agencies of our KN95 masks related to their tests of the effectiveness of the masks and are closely monitoring CDC and FDA regarding their guidance on masks. We will continue to share documentation of FDA registration and listing.

Odoo - Sample 1 for three columns

N95 Masks

In the US, the most commonly available and well-known respirators are the N95, which filter up to 95% of particles and create an air tight seal around the face. These type of respirator masks are not specifically regulated by the FDA, instead they are regulated by the CDC and NIOSH. The FDA may regulate an N95 mask if the manufacturer chooses to market the mask for a medical purpose, and in such case it would need an FDA clearance. 

On March 2, 2020, in response to the COVID-19 pandemic, the FDA released guidance that certain NIOSH approved respirators not currently regulated by the FDA were cleared to be used in a healthcare setting by health care personnel during the emergency epidemic.

Odoo - Sample 2 for three columns

FFP2 Respirator Masks

FFP2 respirator masks are certified by the European Union to meet the standards of CE regulation EN 149:2001+A1:2009 for filtering up to 94% of particles. 

In response to the (COVID-19) outbreak the FDA announced that certified European CE EN-149 FFP2 respirator masks are cleared for emergency use.

Odoo - Sample 3 for three columns

KN95 Masks

KN95 masks are regulated by the Chinese government under regulation GB2626-2006 and are rated to filter 95% of particles. In April of 2020, the FDA authorized the use of KN95 as suitable NIOSH alternatives. In May, the FDA limited the use of certain KN95 masks as suitable NIOSH alternatives in a healthcare settings based on expanded eligibility criteria. 

Timeline of Covid-19 Face Piece Respirators

A chronology of regulations, standards and guidelines

  •  

    May 7th 2020

    FDA updated the April guidance, limiting the use of certain KN95 masks in healthcare settings.

    Revisions were made to address concerns about KN95 products that although met standards set forth by the Chinese government, they had not yet been vetted to meet approval of other countries. This revision made additional criteria necessary for eligibility for certain mask to be on the approved list (Appendix A). It also added a process for removal of products that did not meet this eligibility. 

    (Source: FDA  https://www.fda.gov/media/136664/download ).
  •  

    April 8th 2020

    FDA Authorizes Emergency Use of KN95 Masks and FFP2 Masks

    To expand the availability of general use face masks for the general public and particulate filtering face piece respirators for healthcare professionals during the COVID-19 pandemic, the FDA issued guidance authorizing the use of KN95 masks as suitable NIOSH alternatives under certain emergency circumstances. 

    (Source:FDA  https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns  and FDA  https://www.fda.gov/media/136449/download ).
  •  

    March 28th 2020

    FDA announced that certified European CE EN-149 FFP2 respirator masks are cleared for emergency use 

    On March 28th, 2020, the FDA headed the outcry for access to more respirators and announced that certified European CE EN-149 FFP2 respirator masks are cleared for emergency use under certain conditions when there is a shortage of NIOSH approved N95 respirators.


    (Source FDA  https://www.fda.gov/media/136403/download?from=singlemessage&isappinstalled=0  )
  •  

    March 11th 2020

    The World Health Organization (WHO) declares the novel coronavirus (Covid-19) outbreak a global pandemic.

  •  

    March 2nd 2020

    FDA released guidance that certain NIOSH approved respirators are cleared to be used in a healthcare.

    In response to the COVID-19 pandemic, the FDA released guidance that certain NIOSH approved respirators not currently regulated by the FDA are cleared to be used in a healthcare setting by health care personnel during the emergency coronavirus outbreak  

    (Source FDA  https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-and-cdc-take-action-increase-access-respirators-including-n95s ).