K-number	K900499
Device name	LATEX PATIENT EXAMINATION GLOVES
Applicant	Premium Fit
Product code	LYY
Device class	Class I
Decision date	Mar 8, 1990
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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LATEX PATIENT EXAMINATION GLOVES

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