The following data is part of a premarket notification filed by Shandong Kangli Medical Equipment Technology Co., Ltd. with the FDA for Surgical Gown.
| Device ID | K192560 |
| 510k Number | K192560 |
| Device Name: | Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | Shandong Kangli Medical Equipment Technology Co., Ltd. Huiquan East Road, Shizhong District Zaozhuang, CN 277117 |
| Contact | Zhuang Liu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-17 |
| Decision Date | 2020-05-22 |