FDA Non-NIOSH Approved Respirators Manufactured in China

Data Source: FDA   Last Updated: 2020/06/19

On May 7, 2020, the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise one of the eligibility criteria – the criterion for authorization of respirators based on review of test reports from recognized independent test laboratories submitted to the FDA by the manufacturer or importer.

The FDA accordingly removed from Appendix A the respirators that had been authorized under that criterion, regardless of whether they passed or failed the NIOSH testing. Check Removed List

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Manufacturer Model(s) Country
1 3M 9001, 9002, 9501, 9501+, 9501V+,9502, 9502+, 9502V+, 9505+, 9541,9541V, 9542, 9542V, 9552, 9552V China
3 Allmed Medical Products Co., Ltd LP220002 China
6 AOK Tooling Ltd. (aka Shenzhonghai Medical) 20130040, 20130045A, 20180021,20130038, 20190019 China
7 Bei Bei Safety Co Ltd. B702, B702V, B704, B704V China
132 Beijing Topnew Import & Export Co., Ltd. ZY95 China
9 BYD Precision Manufacture Co. Ltd. BYD KN95 Particulate Respirator (Model Number: DG3101) China
12 Chengde Technology Co. KN95 (PM 2.5) Protective Mask China
133 Chongqing Zisun (Zaisheng) Technology Corp., Ltd ZS-ZD-FJ-1, ZS-ZD-WJ-1 China
134 Creative Concepts Manufacturing Ltd. 02676 China
20 Dongguan Arun Industrial Co., LTD KN95 N9 China
137 Foshan Flying Medical Products Co., Ltd.
35 Guangzhou Harley Commodity Company Limited L-103V KN95 China
37 Guangzhou Powecom Labor Insurance Supplies Co., LTD KN95 China
142 Guangzhou Weini Technology & Development Co., Ltd. K320 China
46 Hangzhou San Qiang Safety Protection Products Co., Ltd. 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) China
42 HeiQ Materials AG HVB-FFP2-01 China
141 Jiangyin Chang-hung Industrial China
62 Raxwell Industrial Technology (Shanghai) Co., Ltd. RX9501 China
63 Rizhao Sanqi Medical & Health Articles Co., Ltd RIZ100CVb, 3Q KN95, 3Q FFP2 NR, RIZQ100Sb, 3Q KN95 9505 China
67 Shanghai Dasheng Health Products Manufacture Company, Ltd. DTC3X-1, DTC3X-2, DTC3X-3, DTC3B-1 China
128 Shanghai Gangkai Purifying Products Co. Ltd 8012,8013 China
140 Shenzhen Ende Medical Technology Co., Ltd. China
129 Sure-On Industries Ltd 210-KN95 China
73 Suzhou Bolisi Medical Technology Co., Ltd BS-9501L, BS-9501FL, BS-9502C, BS- 9502FC China
74 Suzhou Sanical Protective Product Manufacturing Co., Ltd Model 8015, Model 9015 China
130 Tengfei Tech. Co. Ltd TF-9006 China
76 Weini Technology Development Co., Ltd FFP2 NR E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820, KN95 958, KN95 951 China