Name: Predicase
Price: 199 USD

K-number	K232654
Device name	Nephron Nitrile, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)
Applicant	Nephron Nitrile, LLC
Product code	LZA
Device class	Class I
Decision date	Mar 20, 2024
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, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl)

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

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