The following data is part of a premarket notification filed by Yanbian Pacific Textile Co., Ltd with the FDA for Surgical Isolation Gown.
| Device ID | K203415 |
| 510k Number | K203415 |
| Device Name: | Surgical Isolation Gown |
| Classification | Gown, Isolation, Surgical |
| Applicant | Yanbian Pacific Textile Co., LTD Longjing Industry Concentration Area Longjing City, CN 133400 |
| Contact | Juan Zhuang |
| Correspondent | Rafi Wong Pacific Fortune Management Inc. 2350 Mission College BLVD, STE 475 Santa Clara, CA 95054 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-19 |
| Decision Date | 2021-05-20 |