Name: Predicase
Price: 199 USD

K-number	K113707
Device name	STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
Applicant	Cardinal Health-Medical Products and Services
Product code	KGO
Device class	Class I
Decision date	Apr 27, 2012
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING

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