Name: Predicase
Price: 199 USD

K-number	K241745
Device name	Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
Applicant	Ksg Medicare Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Sep 11, 2024
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 Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)

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