Appendix A: Authorized Respirators

Appendix A: Authorized Respirators

Updated: June 11, 2020

The Authorized Respirators

Authorized respirators should be used in accordance with CDC’s recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC’s webpage: Strategies for Optimizing the Supply of N95 Respirators.

Please note that this list is updated on a rolling basis as new information becomes available for FDA to review.

Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
Manufacturer Respirator Model(s) Country of Manufacture Instructions for Use

3M

9001, 9002, 9501, 9501+, 9501V+, 9502, 9502+, 9502V+, 9505+, 9541, 9541V, 9542, 9542V, 9552, 9552V

China

Allmed Medical Products Co., Ltd

LP220002

China

 

 

AOK Tooling Ltd. (aka Shenzhonghai Medical)

20130040, 20130045A, 20180021, 20130038, 20190019, 910

China

 

 

 

 

 

 

 

Bei Bei Safety Co Ltd.

B702, B702V, B704, B704V

China

 

 

 

 

Beijing Topnew Import & Export Co., Ltd. TOPNEW IMPORT & EXPORT CO., LTD.

ZY95

China

BYD Precision Manufacture Co. Ltd.

BYD KN95 Particulate Respirator (Model Number: DG3101)

China

Chengde Technology Co.

KN95 (PM 2.5) Protective Mask

China

Chongqing Zisun (Zaisheng) Technology Corp., Ltd.

ZS -ZD-FJ-1, ZS-ZD-WJ-1

China

Dongguan Arun Industrial Co., LTD

KN95 N9

China

Dongguan Sengtor Plastics Products Co., Ltd.

KN95

China

ESound Medical Device Co., Ltd.

20182140615 Folded

China

Fujian Kang Chen Daily Necessities Co, Ltd.

K0450, 57793

China

Guangdong Yidao Medical

YD-002

China

Guangzhou Harley Commodity Company Limited

L-103V KN95

China

Guangzhou Powecom Labor Insurance Supplies Co., LTD

KN95

China

Hangzhou San Qiang Safety Protection Products Co., Ltd.

9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9480V (FFP2), 9980V (FFP3), 9920V (FFP3)

China

HANGZHOU FILTECH INTELLIGENT CO., LTD.

Filtech Face Mask Model F860

China

HeiQ Materials AG

Henan Yadu Industrial Co., Ltd

Hubei Huaqiang High-Tech Co., Ltd.

Jiande Chaomei Daily Chemicals Co.

HVB-FFP2-01

Flat Fold

Flat Fold (Earloop) Non-Sterile

F-Y3-A

China

China

China

China

ORICH Medical Equipment (Tianjin) Co., Ltd.

N95 Folded Form (Non-sterile)

China

Qingdao Miuton Medical Co., Ltd

Stereoscopic type, ear worn KN95 Protective Mask

China

Qingzhou Yaowang Pharmaceutical Co., Ltd

N95-FWJ

China

Raxwell Industrial Technology (Shanghai) Co., Ltd

RX9501

China

http://www.raxwell.cn/e n_US/page/rx9501userins tructions

a/chanpinzhongxin/laodo

ngbaohulei/2020/0414/1

Rizhao Sanqi Medical & Health Articles Co., Ltd

Shandong Haidike Medical Products Co., Ltd.

Shanghai Dasheng Health Products Manufacture Company, Ltd.

Shanghai Gangkai Purifying Products Co. Ltd.

Shanghai Yunqing Industrial Co., Ltd.

Shenyang Shengshi Medical Technology Co., Ltd.

RIZ100CVb, 3Q KN95, 3Q FFP2 NR, RIZQ100Sb, 3Q KN95 9505

N95-V1

DTC3X-1, DTC3X-2, DTC3X-3, DTC3B-1

8022, 8012, 8013

YQD95 KN95

Folding type (non-sterile)

China

 

Shangxian Minimal Invasive Inc.

CD9501

China

Sure-On Industries Ltd

210-KN95

China

Suzhou Bolisi Medical Technology Co., Ltd

BS-9501L, BS-9501FL, BS-9502C, BS- 9502FC

China

Suzhou Sanical Protective Product Manufacturing Co., Ltd

Model 8015, Model 9015

China

Tengfei Tech. Co. Ltd.

TF-9006

China

Weini Technology Development Co., Ltd

FFP2 NR E-300, FFP2 NR E-680, FFP2 NR 952, FFP2 NR F-820, KN95 958, KN95 951

ZHEJIANG LILY UNDERWEAR CO.,LTD

FM0201-966

China

Zhende Medical Co., Ltd.

N9501F

China