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 Name:||Disposable Surgical Gown Rk-3011C|
|Applicant||Xiantao Rhycom Non-woven Products Co., Ltd Chuangye Road, Longhuashan Sub-district, Xiantao, CN|
PureVision Ai, Inc. 111 Town Square Place Suite 1203 Jersey City, NJ 07310 -2784
|CFR Regulation Number||878.4040 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|