Name: Predicase
Price: 199 USD

K-number	K233560
Device name	Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid
Applicant	Eco Medi Glove Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Feb 26, 2024
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid

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