Respirator Models No Longer Authorized

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Respirator Models No Longer Authorized Respirator Models Removed from Appendix A Updated: June 12, 2020 Respirator Models No Longer Authorized These respirator models had been on the list of authorized respirators in Appendix A but no longer meet the EUA eligibility criteria and thus are no longer authorized. Note: As outlined in the EUA, a respirator model with a removal date of May 7, 2020 is eligible for authorization under the revised third criterion if it has had particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) TEB-APR-STP-0059 within 45 calendar days of May 7, 2020, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent. Respirators with removal dates after May 7, 2020 are not eligible for the revised third criterion. A respirator that meets the revised third criterion, or any of the other eligibility criteria in the EUA, is authorized and will be added to Appendix A as an authorized respirator once FDA confirms the eligibility criteria are met. Results from NIOSH’s testing are provided at: https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html. Manufacturer Respirator Model(s) No Longer Authorized Date No Longer Authorized AAB (China) Co., Ltd. KN95 May 7, 2020 Anhui Zhongke Duling Mether M-9501 EN149:2001 FFP2 May 7, 2020 Commercial Appliance Co., Ltd Anshun Health and Medical AKF2002 May 7, 2020 Technology Co., LTD Bei (Dong Shan) Protective B707 May 7, 2020 Supplies Co., LTD Changsha JNEYL Medical JN-9501 May 7, 2020 Equipment Co., Ltd Changzhou Wedream Medical KN95 May 7, 2020 Device Co., Ltd China Nano Technology Co., ZN6005 May 7, 2020 Ltd ZN8005 Chongqing China Nano KN95 ZN6005 May 7, 2020 Technology Co., Ltd. Chongqing Zaisheng ZS-A950 May 7, 2020 Technology Co., Ltd. Chuzhou Qiao Dong Industrial Langie KN95 FFP2 May 7, 2020 Co., Ltd Creative Concepts 02669, 02676, KN95 May 7, 2020 Manufacturing Ltd CTT CO. Ltd. KN95 May 7, 2020 Daddybaby Co. Ltd. KN95 FFP2 May 7, 2020 DongGuan HuaGang KN95-A; KN95-B May 7, 2020 Communication Technology Co., Ltd Dongguan Leihuo Medical CPFM-100, CPFM-101, LH-KN95 May 7, 2020 Device Co., LTD Dongguan Xianda Medical KN95 May 7, 2020 Equipment Co., Ltd Foshan Nanhai Weijian KN95 Model 9051A May 7, 2020 Sanbang Protective Equipment Technology Co., Ltd Fujian Kang Chen Daily K0450, 57793 June 6, 2020 Necessities Co, Ltd. Fujian Pageone Garment Co., KN95 May 7, 2020 Ltd Fujian Yongtai Sanlian N95 May 7, 2020 Garment Co., Ltd. Guangdong Fei Fan MStar KN95 May 7, 2020 Technology Ltd. Guangdong Golden Leaves 8862 KN95 May 7, 2020 Technology Development Co., Ltd. Guangdong Kaper Protection KP-K02 (N95) May 7, 2020 Technology Co., Ltd Guangdong Nuokang Medical KN95 May 7, 2020 Technology Co., Ltd. Guangdong ZhiZhen Biological KN95 May 7, 2020 Medicine Co., LTD Guangzhou Aiyinmei Co., LTD A&F KN95 May 7, 2020 Guangzhou Nan Qi Xing KN95 May 7, 2020 Nonwoven Co. Ltd Guangzhou Sunjoy Auto Earhook folding type K1-K100 May 7, 2020 Supplies Co., LTD Headband folding type K1-K100 Guangzhou Yihere Medical YH-MFK-B95, YH-MFK-Z95 May 7, 2020 Technology Development Co., Ltd. Guizhou Bocai Medical Device Bocai KN95 May 7, 2020 Co., Ltd. Henan Fengzhihuang HF/KN95-3 May 7, 2020 Industrial Co., Ltd Henan Youmaisi Health YMS-AN95 May 7, 2020 Technology Co. LTD Huizhou Green G95200 May 7, 2020 Communication Equipment Manufacturing Co., Ltd Huizhou Huinuo Technology HV-N White 9501A, HV-N White 9501B May 7, 2020 Co., LTD Huizhou Jiahe Cubic KN95 May 7, 2020 Technology Co., LTD Huizhou Lexuslance LK-003 May 7, 2020 Technology Co. Ltd Improve Medical (Hunan) Co., PPDS Disposable Protective Respirator Strap Headband May 7, 2020 Ltd. PPDS Disposable Protective Respirator Ear Hook Jiangsu Weichuangli New WCL-0075 May 7, 2020 Materials Co., Ltd. Jiangsu Yimao Filter Media 9570K May 7, 2020 Co., Ltd Jiangxi Hornet Industrial Co. S-KN95 May 7, 2020 Ltd. Jiangxi Yifengyuan Biological N95, KN95 May 7, 2020 Engineering Co., Ltd. Jinhua Jiadaifu Medical KN95 FFP2 May 7, 2020 Supplies Co. Ltd Jinan Vhold Co., LTD VH-95 May 7, 2020 Juntech (Jiaxing) Healthcare KN95 May 7, 2020 Materials Co. Ltd Lanshan Shendun Technology SD-KN95-01, SD-KN95-02, SD-KN95-C01, SDKN95-C02 May 7, 2020 Co. Panzhihua Gangcheng Group KN95 May 7, 2020 Yasheng Industrial Co., Ltd. Qingdao Orphila Medical OM-KN95-FFP2 May 7, 2020 Technology Co. LTD. Qingyuan Leite Technology GV-0095A, GVHKN95 May 7, 2020 Development Co. Shandong Daddy's Choice Purism KN95 May 7, 2020 Health Science and Technology Co., Ltd Shandong Huishoutang KN95 May 7, 2020 Pharmaceutical Co Shandong Shengquan New SNN70370B (Willow leaf form valveless) May 7, 2020 Material Co., Ltd Shauguan Taijie Protection KN95 May 7, 2020 Technology Co. Ltd. Shenzhen Horb Technology 1.7.02.02.0001 May 7, 2020 Corp., Ltd Shenzhen Missadola 2626-1 KN95 May 7, 2020 Technology Co., Ltd, dba 1AK Medical Supplies Sunright Medical Technology KN95-C3 May 7, 2020 (GuangDong) Co., LTD Tianjin Benmo Medical KN95 May 7, 2020 Equipment Co., Ltd. Winner Medical Co. Ltd. WN-N95FW, WN-N95FG, WN-N95FGIN May 7, 2020 Yiwu Henghao household HH-KN95-001 May 7, 2020 products Co., Ltd Yiwu Yifan Knitting Co. Ltd KN95 May 7, 2020 Zhangzhou Easepal Industrial MASK-104 May 7, 2020 Corp. Zhejiang Baiyi Intelligent KN95 May 7, 2020 Garment Co LTD Zhejiang Shengtai Baby KN95 May 7, 2020 Products Co Ltd Zhengzhou QBS New Material KN95 May 7, 2020 Co., LTD Zhengzhou Ripe Medical Disposable Protective Mask KN95 May 7, 2020 Technology Co., LTD Zhengzhou Ruipu Medical KN95 May 7, 2020 Technology Co.,Ltd Zhengzhou Wanshenshan KN95 May 7, 2020 Healthcare PPE Co., Ltd. ZhongKang protective ZK601 May 7, 2020 equipment technology (Guangzhou) Co., Ltd .
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