K-number	K081592
Device name	POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
Applicant	Quality Gallant Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Dec 3, 2008
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES

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