医疗器械创新网
	本文摘译自FDA 2020年5月26日
以下为详文
授权防护口罩
	
授权防护口罩的使用应依照CDC的提议。
	
在优化使用防护口罩方面的最新的CDC建议,请访问CDC的网页:优化N95防护口罩供应的策略。
	
请注意,此列表随着FDA审查的最新信息而滚动更新。
	
	
授权进口的,非-NIOSH认可的中国制造的防护口罩
	 
	
	
原文:
	
Appendix A: Authorized Respirators
Updated: May 26, 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 | 
| 3M | 9001, 9002, 9501, 9501+, 9501V+, 9502, 9502+, 9502V+, 9505+, 9541, 9541V, 9542, 9542V, 9552, 9552V | China | 
| AOK Tooling Ltd. (aka Shenzhonghai Medical) | 20130040, 20130045A, 20180021, 20130038, 20190019, 901 | China | 
| Bei Bei Safety Co Ltd. | B702, B702V, B704, B704V | China | 
| BYD Precision Manufacture Co. Ltd. | BYD KN95 Particulate Respirator (Model Number: DG3101) | China | 
| Chengde Technology Co. | KN95 (PM 2.5) Protective Mask | China | 
| Fujian Kang Chen Daily Necessities Co, Ltd. | K0450, 57793 | China | 
| Guangzhou Harley Commodity Company Limited | L-103V KN95 | China | 
| Guangzhou Powecom Labor Insurance Supplies Co., LTD | KN95 | China | 
| HeiQ Materials AG | HVB-FFP2-01 | China | 
| Hangzhou San Qiang Safety Protection Products Co., Ltd. | 9420 (FFP2), 9420V (FFP2), 9480 (FFP2), 9480V (FFP2), 9980V (FFP3), 9920V (FFP3) | China | 
| Raxwell Industrial Technology (Shanghai) Co., Ltd | RX9501 | China | 
| Rizhao Sanqi Medical & Health Articles Co., Ltd | RIZ100CVb, 3Q KN95, 3Q FFP2 NR, RIZQ100Sb, 3Q KN95 9505 | China | 
| Shanghai Dasheng Health Products Manufacture Company, Ltd. | DTC3X-1, DTC3X-2, DTC3X-3, DTC3B-1 | China | 
| Shanghai Gangkai Purifying Products Co. Ltd. | 8012, 8013 | 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 |