Name: Predicase
Price: 199 USD

K-number	K122788
Device name	TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O
Applicant	Northstar Healthcare Holdings
Product code	LYY
Device class	Class I
Decision date	Jan 17, 2013
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O

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