Name: Predicase
Price: 199 USD

K-number	K014230
Device name	STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
Applicant	Supermax Glove Manufacturing Sdn Bhd
Product code	KGO
Device class	Class I
Decision date	Mar 13, 2002
Decision	Substantially Equivalent
Regulation	878.4460

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Source

View the full FDA submission: accessdata.fda.gov

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STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)

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