Name: Predicase
Price: 199 USD

K-number	K221773
Device name	Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid
Applicant	Onetexx Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Jul 30, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid

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