Name: Predicase
Price: 199 USD

K-number	K040448
Device name	GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM
Applicant	Rosner-Mautby Meditrade(Thailand) , Ltd.
Product code	LYY
Device class	Class I
Decision date	Mar 23, 2004
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM

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