COVID-19 Update: N95 Masks and PPE Suppliers | Identify whether masks can be imported into the USA
Updated: May 9, 2020
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.
2,401 views0 comments