Name: Predicase
Price: 199 USD

K-number	K231349
Device name	Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)
Applicant	Nephron Nitrile, LLC
Product code	LZA
Device class	Class I
Decision date	Jun 6, 2023
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl)

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