The following data is part of a premarket notification filed by Foshan Nanhai Plus Medical Co Ltd with the FDA for Plus Medical Isolation Gown Level 3.
| Device ID | K212698 |
| 510k Number | K212698 |
| Device Name: | Plus Medical Isolation Gown Level 3 |
| Classification | Gown, Isolation, Surgical |
| Applicant | Foshan Nanhai Plus Medical Co Ltd Shatou Jiujiang Town, Nanhai District Foshan, CN 528208 |
| Contact | Eric Li |
| 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 | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-25 |
| Decision Date | 2022-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973062321356 | K212698 | 000 |
| 16973062321349 | K212698 | 000 |
| 06973062321335 | K212698 | 000 |
| 16973062321325 | K212698 | 000 |
| 16973062321318 | K212698 | 000 |
| 16973062321301 | K212698 | 000 |
| 16973062321295 | K212698 | 000 |
| 16973062321288 | K212698 | 000 |