Name: Predicase
Price: 199 USD

K-number	K050598
Device name	POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)
Applicant	Smart Glove Corp. Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Apr 7, 2005
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 WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)

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