Name: Predicase
Price: 199 USD

K-number	K221164
Device name	Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl
Applicant	Hong Seng Gloves Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Aug 30, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl

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