The following data is part of a premarket notification filed by Xiantao Rhycom Non-woven Products Co., Ltd with the FDA for Disposable Surgical Gown Rk-3011c.
| Device ID | K211060 |
| 510k Number | K211060 |
| Device Name: | Disposable Surgical Gown Rk-3011C |
| Classification | Gown, Surgical |
| Applicant | Xiantao Rhycom Non-woven Products Co., Ltd Chuangye Road, Longhuashan Sub-district, Xiantao, CN |
| Contact | Liu Yang |
| Correspondent | Bryan Wong PureVision Ai, Inc. 111 Town Square Place Suite 1203 Jersey City, NJ 07310 -2784 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-09 |
| Decision Date | 2022-10-28 |