Name: Predicase
Price: 199 USD

K-number	K040108
Device name	OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN
Applicant	Est International Corporation
Product code	LYZ
Device class	Class I
Decision date	Aug 17, 2004
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN

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