Name: Predicase
Price: 199 USD

K-number	K101828
Device name	POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Applicant	Gx Corporation Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Oct 4, 2010
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 LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS

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