Name: Predicase
Price: 199 USD

K-number	K213437
Device name	Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
Applicant	Central Medicare Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Apr 11, 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 Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims

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