Name: Predicase
Price: 199 USD

K-number	K123469
Device name	POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE
Applicant	Wear Safe (Malaysia) Sdn Bhd - Facility II
Product code	LZA
Device class	Class I
Decision date	Feb 19, 2013
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 PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE

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