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
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