Name: Predicase
Price: 199 USD

K-number	K043508
Device name	DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
Applicant	Ansell Healthcare Products, LLC
Product code	KGO
Device class	Class I
Decision date	Jan 19, 2005
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)

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