Name: Predicase
Price: 199 USD

K-number	K121926
Device name	BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM
Applicant	Northstar Healthcare Holdings
Product code	LZC
Device class	Class I
Decision date	Sep 20, 2012
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM

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