Notification RE: NIOSH CA 2021-1038
For Immediate Dissemination: August 20th, 2021
Dear Valued End Users, Partners & Respected Worldwide Regulatory Authorities:
Please note that we have been informed by the Unites States of America (USA) National Institute for Occupational Safety and Health (NIOSH) that we may no longer manufacture, assemble, sell, or distribute N95s as per Notification CA 2021-1038 - effective the date in the notification.
This unforeseen emergency event was not expected, and we are working diligently and regularly communicating with USA NOISH to rectify this situation.
We received notice from USA NIOSH on August 16, 2021 to stop the supply of N95 masks in an effort to battle counterfeit Dasheng Masks in the marketplace. In their correspondence, they stated that they would communicate with us regarding next steps. However, 2 days later an unprecedented action: ALL our USA NIOSH Approvals were suddenly revoked on the afternoon of August 18, 2021 without first informing us.
We believe in the quality and the efficacy our products and we value our long and good standing relationship with our partners at USA NIOSH. We will work with them to rectify all their concerns regarding counterfeits as we always have.
Quick Facts include:
• Dasheng has worked hand in hand with USA NIOSH for 20 years
• USA NIOSH has been to our facilities on an annual basis to inspect and audit
• At the time of the aforementioned notice, Dasheng had 38 USA NIOSH approval numbers for N95s, a top quartile number in terms of manufacturers.
• Our facilities are subject to annual audits for compliance and average 1 inspection per month from our partners.
• Dasheng is a quality manufacturer for 25+ years and have produced 2 billion+ masks conforming to rigorous standards including CE, FDA, and have won many industry accolades.
We have been informed the revocation is mainly related to the consequence of counterfeits; the quality of our products themselves conform wholly to USA NIOSH standards.
• Mask manufactured by Dasheng with valid Lot#s are authentic and safe to use
• These masks were manufactured to standards complaint to strict 42 CFR PART 84 protocols
• Third party testing verification supports and validates our models’ performance
Since COVID-19, there have been many counterfeits of N95 masks using Dasheng’s Trademark, NIOSH approval #s, and design: especially in US in regards to certain models only. The counterfeits are of low quality and endanger the health of wearers. We’re actively working with USA NIOSH to find these counterfeits since last year, and they expressed much appreciation to our efforts. We are working with local enforcement and international regulators consistently to remove these products from the marketplace.
We thank you for your patience and attention during this difficult time. We will provide regular updates as we receive more information and actions in terms of recovering our certifications in the USA.
A special email address has been setup should you have any questions in regards to aforementioned or the authenticity of your masks. Please email us directly to email@example.com
Shanghai Dasheng Health Products Manufacture Co., Ltd.
August 20th, 2021