K-number	K214116
Device name	AAMI4 Isolation Gown
Applicant	Hubei Xinxin Non-Woven Co., Ltd.
Product code	FYC
Device class	Class II
Decision date	Oct 11, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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View the full FDA submission: accessdata.fda.gov

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AAMI4 Isolation Gown

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