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