Name: Predicase
Price: 199 USD

K-number	K002720
Device name	FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO
Applicant	Tillotson Healthcare Corp.
Product code	LYY
Device class	Class I
Decision date	Nov 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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FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO

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