The following data is part of a premarket notification filed by Zhuhai Gaoge Medical Technology Co., Ltd. with the FDA for Surgical Face Mask.
| Device ID | K203732 |
| 510k Number | K203732 |
| Device Name: | Surgical Face Mask |
| Classification | Mask, Surgical |
| Applicant | Zhuhai Gaoge Medical Technology Co., Ltd. 3rd Floor, Flat 5, No. 6 JinYuan One Street, TangJiaWan Town Zhuahai National Hi-tech Industrial Dev Zhuhai, CN 519000 |
| Contact | Xiangliang Cheng |
| Correspondent | Olivia Meng Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No. 26 Qinglan Street, Panyu District Guangzhou, CN 510006 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-21 |
| Decision Date | 2021-06-11 |