Name: Predicase
Price: 199 USD

K-number	K011407
Device name	LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO
Applicant	Sempermed USA, Inc.
Product code	LYY
Device class	Class I
Decision date	Sep 11, 2001
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO

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