K-number	K222128
Device name	Protective Gown AAMI Level 4
Applicant	Kenpax International Limited
Product code	QPC
Device class	Class II
Decision date	Aug 8, 2023
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Protective Gown AAMI Level 4

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