K-number	K211538
Device name	Protect X Level 3 Isolation Gown
Applicant	Azac Group
Product code	FYC
Device class	Class II
Decision date	Nov 17, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Protect X Level 3 Isolation Gown

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