Name: Predicase
Price: 199 USD

K-number	K112988
Device name	POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE
Applicant	Northstar Healthcare Holdings Limited
Product code	LYY
Device class	Class I
Decision date	Nov 9, 2011
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE

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