K-number	K212504
Device name	Isolation Gown AAMI Level 3
Applicant	Kenpax International Limited
Product code	FYC
Device class	Class II
Decision date	Nov 7, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Isolation Gown AAMI Level 3

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