K-number	K230384
Device name	PolyWear® Personal Protective Level 3 Gown
Applicant	PolyConversions, Inc.
Product code	QPC
Device class	Class II
Decision date	Aug 11, 2023
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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PolyWear® Personal Protective Level 3 Gown

Everything you need for a 510(k) submission. Nothing you don't.