Name: Predicase
Price: 199 USD

K-number	K243796
Device name	GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
Applicant	Glove One, LLC
Product code	LZA
Device class	Class I
Decision date	Jun 3, 2025
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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GLOVEONE Powder-Free Nitrile Examination Gloves  Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]

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

GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]