Name: Predicase
Price: 199 USD

K-number	K232064
Device name	Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)
Applicant	Isikel Manufacturing, LLC
Product code	LZA
Device class	Class I
Decision date	Oct 2, 2023
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate)

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