Name: Predicase
Price: 199 USD

K-number	K083571
Device name	ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR
Applicant	Purna Bina Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Aug 13, 2009
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR

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