Name: Predicase
Price: 199 USD

K-number	K231365
Device name	Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves
Applicant	Anhui Intco Medical Products Co., Ltd.
Product code	LZA
Device class	Class I
Decision date	Mar 1, 2024
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves

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