Name: Predicase
Price: 199 USD

K-number	K221027
Device name	Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
Applicant	Allmed Medical (Hubei) Protective Products Co., Ltd.
Product code	FYC
Device class	Class II
Decision date	Aug 12, 2022
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))

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