Name: Predicase
Price: 199 USD

K-number	K935917
Device name	CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	KGB
Device class	Class I
Decision date	Feb 4, 1994
Decision	Substantially Equivalent
Regulation	868.5570

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Source

View the full FDA submission: accessdata.fda.gov

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CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES

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