Name: Predicase
Price: 199 USD

K-number	K163168
Device name	Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)
Applicant	Hebei Hongtai Plastic Products Company Limited
Product code	LYZ
Device class	Class I
Decision date	Feb 23, 2017
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)

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