The following data is part of a premarket notification filed by Xianning Marveldas Protective Articles Co.,ltd. with the FDA for Surgical Gown.
| Device ID | K212812 |
| 510k Number | K212812 |
| Device Name: | Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | Xianning Marveldas Protective Articles CO.,Ltd. Guishan Road #30, Hi-New Industrial Xianning, CN |
| Contact | Zhuxiao Kang |
| Correspondent | Salon Chen IMD Medical & Drug Technology Service Institutions Room 308, Building 11, No. 23, Jinqu Road, Wanjiang Street Dongguan, CN 523069 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-03 |
| Decision Date | 2022-11-16 |