Name: Predicase
Price: 199 USD

K-number	K050455
Device name	SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES
Applicant	Zibo Blue Intco Plastic & Rubber Products Co., Ltd.
Product code	LYZ
Device class	Class I
Decision date	Mar 29, 2005
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES

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