N95 MADE IN USA Face Masks (box of 25)

Pure Environments by Shatkin F.I.R.S.T. is manufacturing USA Made N95 disposable face masks in
Buffalo, NY USA! The quality and manufacturing practices are second to none. We have built a clean room
environment for the manufacturing of these masks and have received our approvals for use of the facility here in
Amherst.
In the spirit of full transparency, here is the current standing on the N95 /FFP2 face masks, which we have opted to
make available prior to NIOSH certification, due to the desperate need for these masks in our
current worldwide situation and the shortages of N95 masks.
The face masks are available immediately and orders will be shipped on a first come first served
basis.
These masks are currently listed as FDA Class 1 device listing number 401288. The masks we are manufacturing
have been laboratory tested (see attached testing documents and technical data sheet). We are currently having
further testing done by two (2) USA Testing facilities, JCS Labs and Vance Laboratory. We are also having additional testing
done by SGS Laboratory, (the world's leading inspection, verification, testing and certification company) under
European standard EN 149.
Currently, these masks are at ICS Labs awaiting pre-NIOSH Certification testing. We have received the Vance
Laboratory pre-NIOSH Certification test results confirming that our masks do comply with the stringent NIOSH
requirements for both particulate filtration efficiency and inhalation resistance. These results are included in this
document. The masks will be sold as laboratory tested N95 filtration masks, conforming to N95 standards prior to
NIOSH approval which can take up to 6 months. After NIOSH approval, the masks will then be listed with the FDA and
CDC as USA made N95 NIOSH respirator masks. The pre-certification testing is a necessary step in the NIOSH
certification process.
Due to the urgency of the situation, we are making these masks available prior to final NIOSH approval.
NIOSH: Due to the 6 month lead time for NIOSH approval, these masks will not be NIOSH approved. However, the FDA
now accepts these test reports under the standard of EN 149 for N95/FFP2 registration.
These masks comply with the requirements of EU regulation (EU) 2016/425 (see testing results below) for
Personal Protective Equipment and meet the requirements of European standard EN 149:2001 + Al:2009.
• Masks are model PESF-N95H FFP2 NR: Designed to protect the wearer against the
inhalation of both droplets and particles suspended in the air.
• FFP2 masks that meet the EN-149 standard are the closest to N95 masks in the ability to filter particles.
• See attached 3M technical bulletin describing similarities between N95 NIOSH regulated and EN 149:2001 FFP2
"During pandemic or emergency situations, health authorities often reference these standards when making
respirator recommendations, stating, for example, that certain populations should use an "N95, FFP2, or
equivalent" respirator.
• Our masks have passed stringent laboratory testing and are undergoing additional testing at USA and
European Laboratories including JCS Labs as well as SGS Laboratory, for European Standards