Original Title: Blockbuster: Chinese Standard KN95 Mask Is Officially Recognized by the United States (List of Authorized Manufacturers Attached On April 3, the FDA of the United States published on its official website a document on EUA authorization for respirators (masks) produced in China that have not been certified by NIOSH. The US FDA has excluded the Chinese standard KN95 masks from the scope of EUA authorization. This newly issued document marks that the KN95 masks produced according to the Chinese standard have been officially recognized by the US authorities. There are three principles for obtaining EUA authorization for masks produced in China: 1. Owned by one or more For manufacturers of NIOSH certified products, FDA may verify other models of filtering facepiece respirators (FFRs) manufactured in accordance with the applicable licensing standards in other countries; 2. Authorized by regions other than China ? FDA can verify; 3. Test report issued by an independent testing laboratory ? FDA may verify that the performance of the product is in compliance with applicable test standards. Note: If this principle is met, manufacturers of masks designed and validated in accordance with Chinese standards can obtain EUA authorization. Expand the full text The FDA made the most crucial point with a footnote in very small print. Source: FDA website Source: Global Times article with pictures Chinese manufacturers can submit different application materials according to these three principles. The list of application materials to be submitted is as follows: 01 If the first principle mentioned above is met, the following materials shall be submitted: — — Manufacturer's name, model and NIOSH approval number of NIOSH approved respirator; -The manufacturer's name, address,Medical Disposable Coverall, model number, and a copy of the product label of the respirator for which authorization is sought; -The number of respirators expected to be imported in a public health emergency. 02 If the second principle mentioned above is met, the following materials shall be submitted: -The manufacturer's name,Quickly Delivery Disposable Protective Clothing, address, model number, and a copy of the product label of the respirator for which authorization is sought; — — marketing authorization documents/certificates issued by other regulatory bodies or conformity assessment bodies (including authorization numbers and names of conformity assessment bodies); -Certificate of compliance with applicable standards; -The number of respirators expected to be imported in a public health emergency. 03 If the third principle mentioned above is met, the following materials shall be submitted: -The manufacturer's name, address, KN95 Mask with Fast Shipping ,Full Body Disposable Coverall, model number, and a copy of the product label of the respirator for which authorization is sought; -Name of testing agency; -Certificate of compliance with applicable standards; -The test report shows that it meets the applicable performance standards; — The number of respirators expected to be imported in a public health emergency. There are 2 manufacturers of non-NIOSH certified respirators manufactured in China approved by FDA on April 3, 2020, and the specific models are as follows: 1. BYD Precision Manufacturing Co Ltd BYD Model DG3101 KN95 Particulate Respirator (respirator); 2. The model of Weini Technology Development Co., Ltd is Respirators (respirators) for FFP2 NR E-300, FFP2 NR E-680, FFP NR 952, FFP NR F-820. FDA Document Link: https://www.fda.gov/media/136664/download. Link of authorized enterprises: https://www.fda.gov/media/136663/download (the list of FDA authorized enterprises will be updated continuously) Contributed by: Xiamen Customs 4006370880 The global epidemic situation is becoming more and more serious. Once again, Xishida responded to the needs of customers, set up a special export team of epidemic prevention materials, integrated a set of rapid response service mode, and provided door-to-door supply chain integration services for enterprise customers, such as domestic pick-up and transportation, trade agency (with the second type of medical device sales qualification), export customs clearance, international booking and overseas distribution.
Epidemic prevention materials include: masks, protective suit, gloves,Medical Disposable Coverall, forehead temperature guns, disinfection supplies, medical equipment and other products. Please refer to the following figure ↓ ↓ ↓ Return to Sohu to see more Responsible Editor:. zjyuan-group.com