Name: Predicase
Price: 199 USD

K-number	K231643
Device name	Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Applicant	Syntex Healthcare Products Co., Ltd.
Product code	LZA
Device class	Class I
Decision date	Sep 8, 2023
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

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