Disposable Surgical Gown

Gown, Surgical

Shandong Zhushi Pharmaceutical Group Co., Ltd

The following data is part of a premarket notification filed by Shandong Zhushi Pharmaceutical Group Co., Ltd with the FDA for Disposable Surgical Gown.

Pre-market Notification Details

Device IDK210510
510k NumberK210510
Device Name:Disposable Surgical Gown
ClassificationGown, Surgical
Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd No.6 Shande Road, Shan County Heze,  CN 274300
ContactJunhui Zhu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-22
Decision Date2021-08-12

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