Name: Predicase
Price: 199 USD

K-number	K042574
Device name	ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)
Applicant	Cardinalhealth
Product code	KGO
Device class	Class I
Decision date	Dec 8, 2004
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)

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