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 |