Name: Predicase
Price: 199 USD

K-number	K071414
Device name	BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant	Molnlycke Health Care Us, LLC
Product code	KGO
Device class	Class I
Decision date	Sep 10, 2007
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

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