Name: Predicase
Price: 199 USD

K-number	K220943
Device name	Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim
Applicant	Eco Medi Glove Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Jul 19, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim

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