Name: Predicase
Price: 199 USD

K-number	K143346
Device name	Powder-Free White Vinyl Patient Examination Gloves
Applicant	Zibo Changda Plastic Products Company, Limited
Product code	LYZ
Device class	Class I
Decision date	Jul 22, 2015
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Powder-Free White Vinyl Patient Examination Gloves

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