K-number	K142862
Device name	POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).
Applicant	Careplus (M) Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Jan 16, 2015
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).

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