K-number	K241214
Device name	ProPel SG3 Surgical Gown
Applicant	Standard Textile Co., Inc.
Product code	FYA
Device class	Class II
Decision date	Sep 10, 2024
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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ProPel SG3 Surgical Gown

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ProPel SG3 Surgical Gown