We want to introduce you to BenVCapital, a partner in a consortium of 7 facilities manufacturing FDA/CE- Approved Commercial Grade KN95 masks (GB2626-2006/2019 Standard) to which our CEO sits on the board of directors. In addition to the seven facilities manufacturing the KN95 masks, a distinct facility exclusively produces mask accessories such as ear hooks, while another manufactures our CE & FDA approved SARS-CoV-2 Antibody Test Strips. In addition, BenVCapital will be offering branded KN95 masks with the approved certifications. With 335MM masks already produced by our partnership plants in the last month, and 600MM in production for delivery in the coming month, we know of no other manufacturer with the scale, experience or infrastructure to deliver near limitless capacity within a 15-day time-frame. BenVCapital’s success stems from our dedication to maintaining complete control over the end-to-end delivery, thus allowing us to offer prices as low as 1.89USD/mask (4.1MM units plus) including shipping. We are able to deliver to nearly any location worldwide through our own charter flights on 747s & 767s (current client centers include Canada, Europe, South America, Mexico, Germany, France and the U.S.). Below is a link to a press release providing an overview of recent transactions:
BenVCapital has been included in the shortlist of recommendations by the Canadian Government and strictly sources the Commercial Grade KN95 masks (GB 2626-2006/2019) that have been approved for medical and emergency use pursuant to the Canadian Health Minister’s Interim order respecting the importation and sale of medical devices for use in relation to COVID-19, meeting the standard of GB 2626- 2006, GB 2626-2019, and GB 19083-2010. (Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical- devices/masks-respirators-covid19.html Respirators Approved Under Standards Used in Other Countries That Are Similar to NIOSH-Approved N95 Respirators)
On April 3, 2020, in response to continued respirator shortages, the FDA issued a new EUA (Emergency Use Authorization) for non-NIOSH-approved N95 respirators made in China, which makes the KN95 respirators manufactured by BenVCapital’s partner facilities eligible for authorization if certain criteria are met, including evidence demonstrating that the respirator meets certain standards (Such as the GB2626-2006/2019 being sold by BenVCapital). (Source: https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs- shortages-surgical-masks-and-gowns-during-covid-19-pandemic)
Further, the FDA released a list of Respirator Models No Longer Authorized and Removed from Appendix A (https://www.fda.gov/media/137928/download) while Health Canada also released a KN95 respirator recall list (https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73137a-eng.php.). Neither the products nor the manufacturing partners of BenVCapital are currently featured on the FDA’s list of masks that are no longer authorized, which list was updated on June 2, 2020, nor the respirator recall list issued by Health Canada on May 10, 2020 and further updated on June 2, 2020.
Expanding our portfolio of healthcare products, BenVCapital has secured the rights to distribute the SARS- CoV-2 Antibody Test Strip which has FDA, CE and ANVISA Certification. Our partnership plant is currently manufacturing over 10M units per month ready for worldwide distribution.
For additional specifications on the KN95 Mask you can visit https://buyandsell.gc.ca/specifications-for- COVID-19-products (Please see “Table 2” – also illustrated below).
(Specifications, Delivery Lead Times, FDA reports, CE Certifications, Transaction Procedures, Proof of Production, information on our team, can all be provided)
We would love to discuss how we may be able to assist your efforts.
Senior Vice President, U.S. Strategy & Business Development
Email: [email protected]