Name: Predicase
Price: 199 USD

K-number	K032024
Device name	POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
Applicant	Shen Wei (Usa), Inc.
Product code	LZA
Device class	Class I
Decision date	Oct 29, 2003
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 GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)

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