Disposable Surgical Gown Rk-3011C

Gown, Surgical

Xiantao Rhycom Non-woven Products Co., Ltd

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.

Pre-market Notification Details

Device IDK211060
510k NumberK211060
Device Name:Disposable Surgical Gown Rk-3011C
ClassificationGown, Surgical
Applicant Xiantao Rhycom Non-woven Products Co., Ltd Chuangye Road, Longhuashan Sub-district, Xiantao,  CN
ContactLiu Yang
CorrespondentBryan Wong
PureVision Ai, Inc. 111 Town Square Place Suite 1203 Jersey City,  NJ  07310 -2784
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-09
Decision Date2022-10-28

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