Name: Predicase
Price: 199 USD

K-number	K082448
Device name	DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED
Applicant	Rich Mountain Medical Products, Inc.
Product code	LYZ
Device class	Class I
Decision date	Dec 10, 2008
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED

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