Name: Predicase
Price: 199 USD

K-number	K222181
Device name	Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
Applicant	Iconic Medicare Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Jan 11, 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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Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate

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