Name: Predicase
Price: 199 USD

K-number	K050122
Device name	POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)
Applicant	Smart Glove Corp. Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Apr 18, 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 (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)

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