Name: Predicase
Price: 199 USD

K-number	K192290
Device name	50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown
Applicant	Xuchang Zhengde Environstar Medical Products Co., Ltd.
Product code	FYA
Device class	Class II
Decision date	Apr 30, 2020
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown

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