Name: Predicase
Price: 199 USD

K-number	K200539
Device name	Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
Applicant	Sri Trang Gloves (Thailand) Public Company Limited
Product code	LZA
Device class	Class I
Decision date	Apr 9, 2020
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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

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