The following data is part of a premarket notification filed by Anhui Medpurest Medical Technology Co.,ltd with the FDA for Disposable Surgical Gowns.
| Device ID | K202532 |
| 510k Number | K202532 |
| Device Name: | Disposable Surgical Gowns |
| Classification | Gown, Surgical |
| Applicant | Anhui Medpurest Medical Technology Co.,Ltd No.188,Wenyuan Road, Zhumeng New Zone Anqing, CN 246003 |
| Contact | Long Shushan |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-01 |
| Decision Date | 2021-08-21 |