醫療器械創新網
本文摘譯自FDA 2020年5月26日
以下為詳文
授權防護口罩
授權防護口罩的使用應依照CDC的提議。
在優化使用防護口罩方面的最新的CDC建議，請訪問CDC的網頁：優化N95防護口罩供應的策略。
請注意，此列表隨著FDA審查的最新信息而滾動更新。
授權進口的，非-NIOSH認可的中國制造的防護口罩
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
|
