K-number	K172445
Device name	RoyalGuard Surgical Gown, i600, Breathable
Applicant	Gri Medical & Electrical Technology Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Dec 8, 2017
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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RoyalGuard Surgical Gown, i600, Breathable

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