Name: Predicase
Price: 199 USD

K-number	K014134
Device name	POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
Applicant	Supergrade Healthcare Products Sdn. Bhd.
Product code	FMC
Device class	Class I
Decision date	Jan 22, 2002
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)

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