Name: Predicase
Price: 199 USD

K-number	K190077
Device name	Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove
Applicant	Molnlycke Health Care Us, LLC
Product code	KGO
Device class	Class I
Decision date	May 24, 2019
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove

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