K-number	K210510
Device name	Disposable Surgical Gown
Applicant	Shandong Zhushi Pharmaceutical Group Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Aug 12, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Surgical Gown

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