인터넷을 통해 방역마스크(KN95)를 구입하실 때 제조사(manufacturer)를 꼭 확인하세요.
특히 중국에서 생산된 마스크들이 효능이 없는 경우가 많아서, 미국 지정 기관(NIOSH)에서 CDC's standard 통과하여 승인된 마스크들을 발표하고 주의를 요하고 있어요. (The USFDA has banned faulty KN95 masks from 65 overseas manufacturers three weeks after tests found they were ineffective against the COVID19.)
- Factors to Consider When Planning to Purchase Respirators from Another Country:
https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/international-respirator-purchase.html - FDA로부터 승인허가받은 14개 제조사 리스트:
(The list of FDA approved respirator manufacturers (only 14) includes):- 3M
- AOK Tooling Ltd. (AKA Shenzhonghai Medical)
- Bei Bei Safety Co Ltd.
- BYD Precision Manufacture Co. Ltd.
- Fujian Kang Chen Daily Necessities Co, Ltd.
- Guangzhou Harley Commodity Company Limited
- Guangzhou Powecom Labor Insurance Supplies Co., LTD
- HeiQ Materials AG
- Hangzhou San Qiang Safety Protection Products Co., Ltd.
- Rizhao Sanqi Medical & Health Articles Co., Ltd
- Shanghai Dasheng Health Products Manufacture Company, Ltd.
- Suzhou Bolisi Medical Technology Co., Ltd
- Suzhou Sanical Protective Product Manufacturing Co., Ltd
- Weini Technology Development Co., Ltd
- FDA로부터 승인 받지 못한 제조사 리스트 (manufactures that are NO longer approved by the FDA include):
- CTT Co, Ltd (87 percent FE)
- Daddybaby Co. Ltd (91.15 percent FE)
- Dongguan Xianda Medical Equipment Co., Ltd. (24.10 percent FE)
- Guangdong Fei Fan Mstar Technology LTD (61.60 percent FE)
- Guangdong Nuokang Medical Technology Co., Ltd. (24.22 percent FE)
- Huizhou Huinuo Technology Co., Ltd. (88.1 percent FE)
- Lanshan Shendun Technology Co., Ltd. (94.91 percent FE)
- The complete list of banned KN95 masks with model numbers can be found here.
- Certified equipment list include all types of mask
- USFDA 승인된 제조회사 및 제품 검색 (estalishment registration & device listing)
