Name: Predicase
Price: 199 USD

K-number	K010078
Device name	GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
Applicant	Guthrie Medicare Products (Melaka) Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Jan 29, 2001
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)

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