K-number	K212861
Device name	Surgical Gown, Reinforced Surgical Gown
Applicant	Wuhan Zonsen Medical Products Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Dec 15, 2021
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Surgical Gown, Reinforced Surgical Gown

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