K-number	K212925
Device name	Disposable Surgical Gown
Applicant	Henan Robestain Medical Products Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Dec 13, 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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