Name: Predicase
Price: 199 USD

K-number	K120336
Device name	NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U
Applicant	Hartalega Sdn Bhd
Product code	LZC
Device class	Class I
Decision date	Jun 25, 2012
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U

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