Name: Predicase
Price: 199 USD

K-number	K210944
Device name	Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
Applicant	Harbour Health, LLC
Product code	LZA
Device class	Class I
Decision date	Apr 29, 2021
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 Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)

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