Name: Predicase
Price: 199 USD

K-number	K983489
Device name	ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)
Applicant	Ansell Perry
Product code	KGO
Device class	Class I
Decision date	Dec 14, 1998
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)

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