Name: Predicase
Price: 199 USD

K-number	K191092
Device name	Powder-Free Vinyl Patient Examination Gloves, Yellow Color
Applicant	Anhui Intco Medical Products Co., Ltd.
Product code	LYZ
Device class	Class I
Decision date	Jul 22, 2019
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 Vinyl Patient Examination Gloves, Yellow Color

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