Name: Predicase
Price: 199 USD

K-number	K102189
Device name	POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
Applicant	Latexx Manufacturing Sdn.Bhd.
Product code	LZC
Device class	Class I
Decision date	Mar 14, 2012
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 NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM

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