Name: Predicase
Price: 199 USD

K-number	K201531
Device name	Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Applicant	Hartalega Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Aug 5, 2020
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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

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