Name: Predicase
Price: 199 USD

K-number	K081315
Device name	POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT)
Applicant	Gx Corporation Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Aug 11, 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 EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (PINK, BLACK, GREY, AND BLUE PEPPERMENT)

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