Name: Predicase
Price: 199 USD

K-number	K222449
Device name	Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
Applicant	Better Care Plastic Technology Co., Ltd.
Product code	LZC
Device class	Class I
Decision date	Aug 27, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)

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