FDA最新防护口罩中国18企业白名单
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
|
