K-number	K173847
Device name	Disposable Ultra Reinforced Surgical Gown
Applicant	Xiantao Rayxin Medical Products Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Jan 16, 2019
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Ultra Reinforced Surgical Gown

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