Name: Predicase
Price: 199 USD

K-number	K153028
Device name	Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
Applicant	Zibo Huiying Medical Products, Co. , Ltd.
Product code	LYZ
Device class	Class I
Decision date	Feb 5, 2016
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue

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