Name: Predicase
Price: 199 USD

K-number	K051318
Device name	POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR)
Applicant	Platinum Glove Industries Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Jun 17, 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 GLOVES (WHITE, BLUE, AND PURPLE COLOR)

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