Name: Predicase
Price: 199 USD

K-number	K211422
Device name	Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown
Applicant	Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Jul 2, 2021
Decision	Substantially Equivalent
Regulation	878.4040

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown

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