Rain8 Releases FDA EUA and CE N95/FFP2 Masks in Commercial Packs
Updated: Jul 5, 2020
In late March of 2020, the US FDA realized the need for Emergency Use Authorizations (EUAs) for "N95-type" filtering face-piece respirators (FFRs) in order to meet demand for critical protection of health care practitioners (HCPs in US FDA parlance). N95-type FFRs are devices that filer at least 95% of certain particle sizes that are related to the sizes of virus particles.
Under normal circumstances, the US FDA approves FFRs that are previously approved by the National Institutes of Occupational Safety and Health (NIOSH). In early April 2020 (April 3) the FDA issued a number of EUAs for N95-type FFRs that were manufactured in China.
On May 7 2020, the FDA essentially retracted their April 3 decision and removed most of the FFRs manufactured in China from their FFR EUA list.
Yet another FDA policy reversal threw the market for FFRs into chaos and once again sent supply chain managers like Rain8 back into high-gear to help suppliers from China understand the new FDA requirements and how to develop and submit test results to the FDA to attain yet another EUA.
Since April 3, 2020, Rain8 had several suppliers with FDA EUAs permitting sale of their products into the US market.
After a couple of months of work, Rain8 is happy to announce that we have a supplier of commercially-packed N95-type FFRs that now have new and hopefully, lasting, FDA EUA.
Contact us here: https://www.raineightsourcing.com/contact for more information about the contents of this article or how we may assist you with a custom product or service search to meet your business needs.
Rain8 Group, http://www.raineight.com/, has over 20 years experience in China market-entry and business development. Rain8 Sourcing, https://www.raineightsourcing.com/, has over 10 years experience in developing and managing supply chains in China. Rain8 Group and Rain8 Sourcing are wholly-owned subsidiaries of Precision Arrow Placement LLC, http://topranger.us/, a producer of wired and wireless cloud-based sensor networks operating over LoRa WAN for the industrial and agri-tech markets.
Rain8 partners with the Chinese central government and with influential Chinese industry organizations to achieve superior results for our clients including:
○ product quality,
○ product authenticity, and;
○ security of financial transactions.
Visit our partner, The Chinese Council for Promotion of International Trade (CCPIT) here: http://en.ccpit.org/info/index.html