Name: Predicase
Price: 199 USD

K-number	K063581
Device name	SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
Applicant	Pt Mahakarya Inti Buana
Product code	LYY
Device class	Class I
Decision date	Mar 15, 2007
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

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