Name: Predicase
Price: 199 USD

K-number	K082647
Device name	POWDERED VINYL PATIENT EXAMINATION GLOVES
Applicant	Tangshan Dar Plastic & Rubber Products Co. , Ltd.
Product code	LYZ
Device class	Class I
Decision date	Jul 22, 2009
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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POWDERED VINYL PATIENT EXAMINATION GLOVES

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