Name: Predicase
Price: 199 USD

K-number	K022818
Device name	MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
Applicant	Smart Glove Corp. Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Sep 17, 2002
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR

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