The following data is part of a premarket notification filed by Henan Yadu Industrial Co., Ltd. with the FDA for Yadu Surgical Gowns.
| Device ID | K220092 |
| 510k Number | K220092 |
| Device Name: | YADU Surgical Gowns |
| Classification | Gown, Surgical |
| Applicant | HeNan YADU Industrial Co., Ltd. No. 234, West Jianpu Road Changyuan, CN 453400 |
| Contact | Charles Shen |
| Correspondent | Charles Shen Manton Business And Technology Services 37 Winding Ridge Oakland, NJ 07436 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-12 |
| Decision Date | 2022-10-07 |