COVID-19 Update: N95 Masks and PPE Suppliers | Identify whether masks can be imported into the USA

Updated: May 9

The guidance around masks is continuing to expand and to be refined. The U.S. Food and Drug Administration (FDA) is now offering guidance for KN95 masks, which are a Chinese-equivalent of N95 masks. Heathlife will continue to update that information for instruction to choose the right Mask suppliers.


The Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China Updated: April 24, 2020 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.


Updated: May 7, 2020

1.3M

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

China


2.AOK Tooling Ltd. (aka Shenzhonghai Medical) 20130040, 20130045A, 20180021, 20130038, 20190019

China


3.Bei Bei Safety Co Ltd.

B702, B702V, B704, B704V

China


4.BYD PrecisionManufacture Co.Ltd.

BYD KN95 Particulate Respirator(Model Number: DG3101)

China


5.Fujian Kang Chen Daily Necessities Co, Ltd.

K0450, 57793

China


6.Guangzhou Harley Commodity Company Limited

L-103V KN95

China


7.GuangzhouPowecom LaborInsurance Supplies Co., LTD

KN95

China


8.HeiQ Materials AG

HVB-FFP2-01

China


9.Hangzhou San Qiang Safety Protection Products Co., Ltd.

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

China


10.Rizhao Sanqi Medical & Health Articles Co., Ltd

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

China


11.Shanghai DashengHealth ProductsManufacture Company, Ltd.

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

China


12.Suzhou Bolisi Medical Technology Co., Ltd

BS-9501L, BS-9501FL, BS-9502C, BS9502FC

China


13.Suzhou Sanical Protective Product Manufacturing Co., Ltd

Model 8015, Model 9015

China


14.Weini Technology Development Co., Ltd

FFP2 NR E-300, FFP2 NR E-680,FFP2 NR 952, FFP2 NR F-820, KN95958, KN95 951

China



Manufacturer


1.3M

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

China

2.AAB (China) Co.,Ltd.

KN95

China

3.Allmed

KN95 Particulate Respirator, LP220002

China 4.Anhui Zhongke Duling Commercial Appliance Co., Ltd Mether M-9501 EN149:2001 FFP2

China

5.Anshun Health and Medical Technology Co., LTD AKF2002

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

8.Bei Bei (DongShan) Protective Supplies Co., LTD B707

China

9.BYD PrecisionManufacture Co.Ltd. BYD KN95 Particulate Respirator(Model Number: DG3101) China

10.Changsha JNEYLMedical EquipmentCo., Ltd JN-9501

China

11.ChangzhouWedream Medical Device Co., Ltd KN95

China

12.ChengdeTechnology Co. KN95 (PM 2.5) Protective Mask

China

13.China NanoTechnology Co.,Ltd ZN6005 ZN8005 China

14.Chongqing China Nano Technology Co., Ltd. KN95 ZN6005

China

15.ChongqingZaishengTechnology Co.,Ltd. ZS-A950

China

16.Chuzhou Qiao Dong Industrial Co., Ltd Langie KN95 FFP2

China

15.Creative Concepts Manufacturing Ltd 02669, 02676, KN95

China

16.CTT CO. Ltd.

KN95

China

17.Daddybaby Co. Ltd.

KN95 FFP2

China


18.Dongguan Arun Industrial Co., LTD

KN95 N9

China


19.Dongguan HuaGang Communication Technology Co., Ltd

KN95-A; KN95-B

China


20.Dongguan Leihuo Medical Device Co., LTD

CPFM-100, CPFM-101, LH-KN95

China


21.Dongguan Sengtor Plastics Products Co., Ltd.

KN95

China


22. Dongguan Xianda Medical Equipment Co., Ltd

KN95

China


23.Foshan Nanhai Weijian Sanbang Protective Equipment Technology Co., Ltd

KN95 Model 9051A

China


24.Fujian Kang Chen Daily Necessities Co, Ltd.

K0450, 57793

China


25.Fujian Pageone Garment Co., Ltd

KN95

China


26.Fujian Yongtai Sanlian Garment Co., Ltd.

N95

China


27.Guangdong Fei Fan MStar Technology Ltd.

KN95

China


28.Guangdong GoldenLeaves TechnologyDevelopment Co., Ltd. 8862 KN95

China

29.Guangdong KaperProtectionTechnology Co., Ltd KP-K02 (N95) China Guangdong

30.Nuokang Medical Technology Co., Ltd. KN95

China

31.GuangdongZhiZhen Biological Medicine Co., LTD KN95 China Guangzhou

32.Aiyinmei Co., LTD A&F KN95

China

33.Guangzhou Harley Commodity Company Limited L-103V KN95

China

34.Guangzhou Nan Qi Xing Nonwoven Co.Ltd KN95

China

35.GuangzhouPowecom LaborInsurance Supplies Co., LTD KN95

China

36.Guangzhou Sunjoy Auto Supplies Co., LTD Earhook folding type K1-K100, Headband folding type K1-K100 China

37.Guangzhou YihereMedicalTechnology Development Co.,Ltd. YH-MFK-B95, YH-MFK-Z95

China

38.Guizhou BocaiMedical Device Co., Ltd. Bocai KN95

China

39.HeiQ Materials AG

HVB-FFP2-01

China

40.Henan FengzhihuangIndustrial Co., Ltd HF/KN95-3

China

41.Henan YoumaisiHealth Technology Co. LTD YMS-AN95

China

42.Huizhou Green Communication Equipment Manufacturing Co., Ltd G95200

China

43.Hangzhou San Qiang Safety Protection Products Co., Ltd. 9420 (FFP2), 9420V (FFP2), 9480,(FFP2), 9480V (FFP2), 9980V (FFP3),9920V (FFP3) China

44.Huizhou HuinuoTechnology Co., LTD HV-N White 9501A, HV-N White 9501B China

45.Huizhou Jiahe Cubic Technology Co., LTD KN95

China

46.Huizhou Lexuslance Technology Co. Ltd LK-003

China


47. Improve Medical (Hunan) Co., Ltd. PPDS Disposable Protective, Respirator Strap Headband, PPDS Disposable Protective, Respirator Ear Hook China

48.Jiangsu Weichuangli New Materials Co., Ltd. WCL-0075

China

49.Jiangsu Yimao Filter Media Co., Ltd 9570K

China

50.Jiangxi Hornet Industrial Co. Ltd. S-KN95

China


51.Jiangxi Yifengyuan Biological Engineering Co., Ltd. N95, KN95

China

52.Jinhua Jiadaifu Medical Supplies Co. Ltd KN95 FFP2

China

53.Jinan Vhold Co.,LTD VH-95

China

55.Juntech (Jiaxing) Healthcare Materials Co. Ltd KN95

China

56.Lanshan Shendun Technology Co. SD-KN95-01, SD-KN95-02, SD-KN95- C01, SDKN95-C02 China

57.Panzhihua Gangcheng Group Yasheng Industrial Co., Ltd. KN95

China


58.Qingdao Orphila Medical Technology Co. LTD. OM-KN95-FFP2

China

59.Qingyuan Leite Technology Development Co. GV-0095A, GVHKN95

China

60.Raxwell Industrial Technology (Shanghai) Co., Ltd. RX9501

China

61.Rizhao Sanqi Medical & Health Articles Co., Ltd RIZ100CVb, 3Q KN95, 3Q FFP2 NR,RIZQ100Sb, 3Q KN95 9505 China

62.Shandong Daddy's Choice Health Science and Technology Co., Ltd Purism KN95

China

63.Shandong Huishoutang Pharmaceutical Co KN95

China

64.Shandong Shengquan New Material Co., Ltd SNN70370B (Willow leaf form valveless) China

64.Shanghai DashengHealth ProductsManufacture Company, Ltd. DTC3X-1, DTC3X-2, DTC3X-3,DTC3B-1 China

65.Shanghai Yunqing Industrial Co.,Ltd. YQD95 KN95

China


66.Shauguan Taijie Protection Technology Co. Ltd. KN95

China

67.Shenzhen Horb Technology Corp., Ltd 1.7.02.02.0001

China

68.Shenzhen Missadola Technology Co., Ltd, dba 1AK Medical Supplies 2626-1 KN95

China

69.Sunright Medical Technology (GuangDong) Co., LTD KN95-C3

China

70.Suzhou Bolisi Medical Technology Co., Ltd BS-9501L, BS-9501FL, BS-9502C, BS9502FC China

71.Suzhou Sanical Protective Product Manufacturing Co., Ltd Model 8015, Model 9015

China

72.Tianjin Benmo Medical Equipment Co., Ltd. KN95

China

73.Weini Technology Development Co., Ltd FFP2 NR E-300, FFP2 NR E-680,FFP2 NR 952, FFP2 NR F-820, KN95958, KN95 951 China

74.Winner Medical Co. Ltd. WN-N95FW, WN-N95FG, WNN95FGIN China


75.Yiwu Henghao household products Co., Ltd HH-KN95-001

China

76.Yiwu Yifan KnittingCo. Ltd KN95

China

77.Zhangzhou Easepal Industrial Corp. MASK-104

China

78.Zhejiang Baiyi Intelligent Garment Co LTD KN95

China

79.Zhejiang Shengtai Baby Products Co Ltd KN95

China

80.Zhende Medical Co., LTD N9501F

China

81.Zhengzhou QBS New Material Co., LTD KN95

China

82.Zhengzhou Ripe Medical Technology Co., LTD Disposable Protective Mask KN95

China

83.Zhengzhou Ruipu Medical Technology Co.,Ltd KN95

China

84.Zhengzhou Wanshenshan Healthcare PPE Co., Ltd. KN95 China

85.ZhongKang protective equipment technology (Guangzhou) Co., Ltd ZK601

China




If the items ARE intended for medical professionals: FDA must be claimed. Information required to file FDA normally includes: Device Listing Number Manufacturer Registration Number Exporter Registration Number 510(k) Premarket Number

Use the Product Classification


FDA Guidance on KN95 Masks FDA is using the CDC Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies information to expand access, which includes KN95s. The Center for Devices is updating the FDA’s website to indicate this, but the approach is in effect now. Our instructions on the entry process for KN95s and others are below: KN95, KN100, KP100, and KP95 Filtering Facepiece Respirators (Standard GB 2626-2006) NOT Under EUA CDC’s Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies identifies respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators. CDC has determined these are suitable alternatives to provide protection during the COVID-19 response when supplies are short when they conform to standards identified and provide a protection factor of at least 10. FDA does not object to the importation and use of these respirators during the emergency.


Decontamination and Reuse of Filtering Facepiece Respirators


This document offers a series of strategies or options to optimize supplies of disposable N95 filtering facepiece respirators (commonly called “N95 respirators”) in healthcare settings when there is a limited supply. It does not address other aspects of pandemic planning; for those, healthcare facilities can refer to COVID-19 preparedness plans. The strategies are also listed in order of priority and preference in the Checklist for Healthcare Facilities: Strategies for Optimizing the Supply of N95 Respirators during the COVID-19 Response in an easy-to-use format for healthcare facilities.