Name: Predicase
Price: 199 USD

K-number	K111134
Device name	NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Applicant	Siem Aempemed Corp., Ltd.
Product code	LZA
Device class	Class I
Decision date	Jan 26, 2012
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

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