Name: Predicase
Price: 199 USD

K-number	K111868
Device name	STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING
Applicant	Cardinal Health-Medical Products and Services
Product code	KGO
Device class	Class I
Decision date	Sep 21, 2011
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING

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