K-number	K051777
Device name	NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
Applicant	Hartalega Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Aug 12, 2005
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)

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