Name: Predicase
Price: 199 USD

K-number	K093264
Device name	VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED
Applicant	Qingdao Lang Hui Import & Export Co., Ltd.
Product code	LYZ
Device class	Class I
Decision date	May 28, 2010
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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VINYL EXAMINATION GLOVE, POWDER FREE, NON-COLORED

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