The following data is part of a premarket notification filed by Foshan Nanhai Plus Medical Co Ltd with the FDA for Standard Surgical Gown (aami Level 3), Reinforced Surgical Gown (aami Level 3).
| Device ID | K210143 |
| 510k Number | K210143 |
| Device Name: | Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) |
| Classification | Gown, Surgical |
| Applicant | Foshan Nanhai Plus Medical CO LTD Shatou Jiujiang Town, Nanhai District Foshan, CN 528200 |
| 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 | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973062320199 | K210143 | 000 |
| 06973062320314 | K210143 | 000 |
| 06973062320321 | K210143 | 000 |
| 06973062320338 | K210143 | 000 |
| 06973062320345 | K210143 | 000 |
| 16973062320359 | K210143 | 000 |
| 16973062320366 | K210143 | 000 |
| 16973062320373 | K210143 | 000 |
| 16973062320380 | K210143 | 000 |
| 06973062320307 | K210143 | 000 |
| 16973062320298 | K210143 | 000 |
| 06973062320215 | K210143 | 000 |
| 06973062320222 | K210143 | 000 |
| 06973062320239 | K210143 | 000 |
| 06973062320246 | K210143 | 000 |
| 06973062320253 | K210143 | 000 |
| 16973062320267 | K210143 | 000 |
| 16973062320274 | K210143 | 000 |
| 16973062320281 | K210143 | 000 |
| 16973062320397 | K210143 | 000 |
| 06973062320000 | K210143 | 000 |
| 06973062320116 | K210143 | 000 |
| 06973062320123 | K210143 | 000 |
| 06973062320130 | K210143 | 000 |
| 06973062320147 | K210143 | 000 |
| 16973062320151 | K210143 | 000 |
| 16973062320168 | K210143 | 000 |
| 16973062320175 | K210143 | 000 |
| 16973062320182 | K210143 | 000 |
| 06973062320109 | K210143 | 000 |
| 16973062320090 | K210143 | 000 |
| 06973062320017 | K210143 | 000 |
| 06973062320024 | K210143 | 000 |
| 06973062320031 | K210143 | 000 |
| 06973062320048 | K210143 | 000 |
| 16973062320052 | K210143 | 000 |
| 16973062320069 | K210143 | 000 |
| 16973062320076 | K210143 | 000 |
| 16973062320083 | K210143 | 000 |
| 06973062320208 | K210143 | 000 |