Name: Predicase
Price: 199 USD

K-number	K211816
Device name	Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant	Brightway Holdings Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Nov 2, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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

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