Name: Predicase
Price: 199 USD

K-number	K110698
Device name	NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE
Applicant	Terang Nusa Sdn Bhd
Product code	KGO
Device class	Class I
Decision date	Dec 7, 2011
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE

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