Name: Predicase
Price: 199 USD

K-number	K232538
Device name	DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
Applicant	Wrp Asia Pacific Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Nov 17, 2023
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL

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