Respirator Models No Longer Authorized by FDA!

Angie SzumlinskiAnnouncements, News

The following is a list of respirator models previously on the list of authorized respirators but no longer meet the EUA eligibility criteria and are no longer authorized.

Date No Longer AuthorizedManufacturerRespirator Model No Longer Authorized
6/6/2020Fujian Kang Chen Daily Necessities C, Ltd.K0450, 57793
5/7/2020AAB (China) Co., LtdKN95
5/7/2020Anshun Health and Medical Technology Co. LTDAKF2002
5/7/2020Bei (Dong Shan) Protective Supplies Co., LTDB707
5/7/2020Changsha JNEYL Medical Equipment Co., LtdJN-9501
5/7/2020Changzhou Wedream Medical Device Co., LtdKN95
5/7/2020Chongqing China Nano Technology Co., LtdZN8005
5/7/2020Chongqing Zaisheng Technology Co., Ltd.ZS-A950
5/7/2020Chuzhou Qiao Dong Industrial Co., LtdLangie KN05 FFP2
5/7/2020Creative Concepts Manufacturing Ltd02669, KN95
5/7/2020CTT CO. Ltd.KN95
5/7/2020Daddybaby Co. Ltd.KN95 FFP2
5/7/2020DongGuan HuaGang Communication Technology Co., LtdKN95-A; KN95-B
5/7/2020Dongguan Leihuo Medical Device Co., LTDCPFM-100, CPFM-101, LH-KN95
5/7/2020Dongguan Xianda Medical Equipment Co., LtdKN95
5/7/2020Foshan Nanhai Weijan Sanbang Protective Equipment Technology Co., LtdKN95 Model 9051A
5/7/2020Fuijan Pageone Garment Co., LtdKN95
5/7/2020Fuija Yongtai Sanilian Garment Co., Ltd.N95
5/7/2020Guangdong Fei Fan MStar Technology LtdKN95
5/7/2020Guangdong Kaper Protection Technology Co., LtdKP-K02 (N95)
5/7/2020Guangzhou Aiyinmei Co., LTDA&F KN95
5/7/2020Guangzhou Sunjoy Auto Supplies Co., LTDEarhook folding type K1-K100, Headband folding type K1-K100
5/7/2020Guangzhou Yihere Medical TechnologyYH-MFK-B95, YH-MF-Z95
5/7/2020Guizhou Bocai Medical Device Co., Ltd.Bocai KN95
5/7/2020Henan Fengzhihuang Industrial Co., Ltd.HF/KN95-3
5/7/2020Henan Youmaisi Health Technology Co. LTDYMS-AN95
5/7/2020Huizhou Huinuo Technology Co., LTDHV-N White 9501B
5/7/2020Huizhour Jiahe Cubic Technology Co., LTDKN95
5/7/2020Huizhou Lexuslance Technology Co. Ltd.LK 003
5/7/2020Improve Medical (Hunan) Co., Ltd.PPDS Disposable Protective Respirator Strap Headband, PPDS Disposable Protective Respirator Ear Hook
5/7/2020Jiangsu Weichuangli New Materials Co., Ltd.WCL-0075
5/7/2020Jiangxi Hornet Industrial Co. Ltd.S-KN95
5/7/2020Jaingxi Yifengyuan Biological Engingeering Co., Ltd.N95, KN95
5/7/2020Jinan Vhold Co., LTDVH-95
5/7/2020Juntech (Jiaxing) Healthcare Materials Co. LtdKN95
5/7/2020Panzhihua Gangcheng Group Yasheng Industrial Co., LtdKN95
5/7/2020Qingdao Orphila Medical Technology Co. LTD.OM-IN95-FFP2
5/7/2020Qingyuan Leite Technology Development Co.GV-0095A, GVHKN95
5/7/2020Shandong Daddy’s Choice health Science and Technology Co., LtdPurism KN95
5/7/2020Shandong Huishoutang Pharmaceutical CoKN95
5/7/2020Shandong Shengquan New Materials Co., LtdSNN70370B (Willow leaf form valveless)
5/7/2020Shauguan Taije Protection Technology Co.KN95
5/7/2020Shenzhen Horb Technology Corp., Ltd1.
5/7/2020Shenhen Missadola Technology Co., Ltd, dba 1AK Medical Supplies2626-1 KN95
5/7/2020Sunright Medical Technology (GuangDong) Co., LTDKN95-C3
5/7/2020Tianjin Benmo Medical Equipment Co., Ltd.KN95
5/7/2020Winner Medical Co. Ltd.WN-N95FG
5/7/2020Yiwu Henghao household products Co., LtdHH-KN95-001
5/7/2020Yiwu Yifan Knitting Co LtdKN95
5/7/2020Zhangzhou Easepal Industrial Corp.MASK-104
5/7/2020Zheijiang Baiyi Intelligent Garment Co LTDKN95
5/7/2020Zhejiang Shengtai Baby Prodcuts Co LtdKN95
5/7/2020Zhengzhou QBS New Material Co., LTDKN95

Please check your current supply of respirators to be sure they are not listed here as they have been removed from the approved FDA list. To see a complete list of products APPROVED please click the link here.

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 particular 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 indicates a minimum and maximum filtration efficiency greater than or equal to 90%. Respirators with removal dates after May 7, 2020 are no eligible for the revised third criterion.