Name: Predicase
Price: 199 USD

K-number	K003771
Device name	ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant	Ansell Healthcare Products, Inc.
Product code	KGO
Device class	Class I
Decision date	Jan 16, 2001
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

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