Name: Predicase
Price: 199 USD

K-number	K230681
Device name	Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
Applicant	Central Medicare Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Oct 2, 2023
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl

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