The Right Type of HELP IS HERE: F.D.A. Approved KN95 Masks with Certified Quality and Fair Market Wholesale Costs.
KN95 Masks are part of the front-line solution to fight COVID-19. Our Purge Virus initiative is helping do our part in reducing the spread of COVID-19 and prevent a resurgence. “Hospitals across the United States are running out of N95 masks, which filter at least 95 percent of particles that are 0.3 microns or larger, including the new coronavirus. N95 masks are tested and certified by the National Institute for Occupational Safety and Health, or NIOSH, a research agency that is part of the Centers for Disease Control and Prevention.
On Friday (April 3, 2020), the F.D.A. issued an emergency use authorization for KN95 masks. Regulated by the Chinese government, they are almost identical in performance to N95 masks. There are slight differences in their specifications, like a variation in the maximum pressure the masks must be able to withstand as a person inhales and exhales. The C.D.C. lists KN95 masks as a suitable alternative when N95s are not available.” – Source Article: New York Times.
The FDA approval set of a whirlwind of activity including offerings by many manufacturers that did not meet the requirements of either the National Institute of Occupational Safety and Health (NIOSH) or the alternative requirements of the Center for Disease Control (CDC).
Two paths to approval for KN95 Masks:
#1: NIOSH Approved KN95 Masks. How to identify a NIOSH-approved respirator? See this link that also includes examples of KN95 masks that are counterfeit and do not meet the requirements: https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html Counterfeit respirators are products that are falsely marketed and sold as being NIOSH-approved and may not be capable of providing appropriate respiratory protection to workers. For your convenience we have also saved the 04.16.2020 file as a PDF here.
#2: EUA Approved KN95 Masks. How to identify an EUA-approved respirator? See this link from the FDA about the Emergency Use Authorization (EUA) approved masks: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/non-niosh-approved-respirator-eua-faq Since other countries approve respirators according to these standards, the devices are evaluated using methods similar to those used by NIOSH, and are still expected to provide adequate protection for healthcare personnel, given shortages of filtering facepiece respirators (FFRs) resulting from the COVID-19 pandemic. Under these circumstances, FDA believes these devices may serve as suitable alternatives for personal respiratory protection during this period of shortage caused by the COVID-19 pandemic. See: CDC’s strategies for optimizing respirator supply.
International Standards for “N95, FFP2, or equivalent” respirators:
• N95 (United States NIOSH-42CFR84)
• FFP2 (Europe EN 149-2001)
• KN95 (China GB2626-2006)
• P2 (Australia/New Zealand AS/NZA 1716:2012)
• Korea 1st class (Korea KMOEL – 2017-64)
• DS (Japan JMHLW-Notification 214, 2018)
We provide the rigorous due diligence, supply chain logistics, shipping insurance, and up to date import certifications to help you navigate the complexity of the unfortunate respirator shortage, during this unprecedented time.
Three Key Factors in KN95 Mask Procurement:
#1: The Right Product Quality and Certification
#2: The Right Price and Reasonable Volume Tiers
#3: The Right Company
These factors apply to other Personal Protection Equipment (PPE) that is also key to help reduce the spread and resurgence of COVID-19. Through partner companies, we are pleased to offer factory-direct wholesale volume pricing on PPE that is in stock in multiple US warehouses.
Why Buy from Purge Virus?
ANSWER: We meet all three of the key criteria.
#1: The Right Product Quality and Certifications
The KN95 Masks and Surgical Masks that we supply meet the rigorous CDC and FDA import requirements of the Emergency Use Authorization (EUA) and third party TESTING, CONFORMITY, COMPLIANCE, and REGISTRATION. We provide the due diligence to ensure that manufacturers have met the authorization requirements by the Chinese and US Governments including Business Licenses of the Manufacturer, Medical Device Licenses, Manufacturer’s Test Reports, Medical Device Registration Certificates, FDA and CE Qualification Certifications required for foreign customs clearance, Certificates of Conformity, Product Batch / Numbers, Product Photographs, and Packaging Photographs.
#2: The Right Price and Reasonable Volume Tiers
KN96 Mask: $2.75 / mask
Surgical Masks: $0.79 / mask
Current Minimum Order Quantity (MOQ): 10,000 Masks. Combined production volume capacity per month: 80 million masks
In May and/or June 2020, we expect to have masks in the US and smaller orders with a minimum of ONE CARTON (1,000 KN95 Masks) should be available for US buyers. Terms and Conditions are subject to the order size. Credit cards are accepted for deposits as well as checks and wire transfers to expedite shipping. Volume orders via ocean shipping container (30 to 35 days) are available as well as air shipping (5 to 7 days, subject to flight availability), which includes added costs.
Buyer beware: Many brokers have rushed into the market and offer inferior quality masks that do not meet FDA import requirements and at price points per KN95 Mask that are significantly higher than pre COVID-19 levels. In some cases, profiteering “middle-men” have elevated the prices, with costs ranging from $4.50 up to $12 each. This April 3, 2020 article highlights some of the high prices charged to date: It’s Bedlam in the Mask Market, as Profiteers Out-Hustle Good Samaritans
Given our factory-direct wholesale relationships, we can provide KN95 Masks for lower than market average costs, and additional volume discounts are also available on a case-by-case basis. We don’t require massive order quantity over 10,000 masks. Our Chinese production partner can produce millions of KN95 Masks each week and the combined full capacity yield per month is tens of millions of KN95 masks.
#3: The Right Company
The KN95 Masks and Surgical Masks are part of the Purge Virus offering, which is our Independence LED initiative to provide support for hospitals, federal and state governments, and also corporations. We have been in business for over 10 years, and our healthcare sector work has included solutions for the US Navy Hospital Ship the Comfort, the US Department of Veterans Affairs Durham Medical Center, Walter Reed National Military Medical Center, Jefferson University Hospital, Kaiser Permanente, and more. For U.S. Government accounts we are registered with the System for Award Management (SAM) and our DUNS# is 967357174 and CAGE Code is 6UXC4. For state and regional governments we have provided solutions for accounts ranging from municipalities in Florida to the California Department of Corrections and Rehabilitation (CDCR). For the California initiative, we were tasked with life safety to develop illumination that could not be weaponized to harm guards or inmates. Across the private sector, our accounts have ranged from MetLife to Morgan Stanley, as well as thousands of smaller companies across the U.S. and overseas (sample market traction).
In conjunction with the KN95 masks, for Purge Virus, we have leveraged our expertise to develop ultraviolet (UV-C) solutions that utilize Germicidal UV Light, which sterilizes the air in heating and cooling ducts at hospitals, schools, and other facilities. The R&D for our COVID-19 LED Phototherapy is another example of our initiative to help mitigate the spread of future pandemics. All of our work to date has served as a foundation for excellent strategic partnerships in the U.S. and around the world. Our factory direct relationship for the KN95 Masks and Surgical Masks allows us to help cost-effectively address the unprecedented challenges of this current COVID-19 crisis.
Our CEO, Charlie Szoradi, is available to share more information with you. Mr. Szoradi is a graduate of the University of Virginia (’89), and he earned his Master’s Degree at the University of Pennsylvania (’93). He is a three-term elected Board Member of the Sustainable Business Network, and we have built an outstanding strategic partnership “eco-system” based on over 100 speaking engagements and 1,000s of client projects. To reach Mr. Szoradi, please email: Charlie@IndependenceLED.com or text: 610-551-5224.
Stay Vigilant with Social Distancing
We encourage you to be careful and follow social distancing guidelines as well as hand washing and other practices to help mitigate the spread of COVID-19.
Purge Virus supports the service men and women that are on the front lines of the war against COVID-19. Given our prior work with the USNS Comfort, it is a natural starting point to provide factory-direct discounts to the US Department of Defense and Homeland Security. We will also expand the discounts to First Responders, starting in Philadelphia, which is where we work. The less money that the government has to spend on masks, the more money that it may have to help with economic recovery.
N E W S
April 12, 2020: Purge Virus KN95 Masks rank #1 as Least Expensive in the KN95 Market Cost Per Unit Comparison by GREENandSAVE Report #: 2020.04.12
April 12, 2020: USA Today reports that President Trump is eager to reopen America. To prevent further spread and resurgence of COVID-19, we need to plan ahead relative to masks. Now is the time for Mayors, Governors, and CEOs to order KN95 masks, given that they take four weeks to arrive via shipping containers.
March 4, 2020: Healthcare workers will need 3.5 billion face masks if the coronavirus outbreak in the United States hits pandemic proportions, the Department of Health and Human Services said on Wednesday. Currently, however, the national emergency stockpile comprises an estimated 12 million N95 respirator masks and 30 million surgical face masks, CNBC reported. That’s about 1% of what’s required.
Distribution Partner for KN95 Masks and PPE:
Given the high volume of requests for Certified KN95 Masks and other In-Stock PPE, we are pleased to partner with PPE Source International, LLC for volume orders over 2,000 units of any given product. CONTACT: Sales@PPEsourceInternational.com. Please make sure to include the desired volume of masks and/or other PPE along with billing and shipping addresses to streamline the response. Also let us know the immediacy of your needs, since new shipments arrive weekly and custom orders are also available by air freight (7 to 10 days) and lower cost shipping containers (running 30 to 35 days).