Name: Predicase
Price: 199 USD

K-number	K221980
Device name	Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
Applicant	Ever Global (Vietnam) Enterprise Corporation
Product code	LYZ
Device class	Class I
Decision date	Feb 6, 2023
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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Disposable Powder Free Vinyl Examination Gloves, Beige/Clear

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