Name: Predicase
Price: 199 USD

K-number	K993912
Device name	AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI
Applicant	Latexx Partners, Inc.
Product code	LYY
Device class	Class I
Decision date	Feb 9, 2000
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI

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