Name: Predicase
Price: 199 USD

K-number	K200581
Device name	Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Applicant	Hartalega NGC Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Apr 25, 2020
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

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