Name: Predicase
Price: 199 USD

K-number	K042618
Device name	LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)
Applicant	La Glove (M) Sdn. Bhd.
Product code	FMC
Device class	Class I
Decision date	Nov 26, 2004
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)

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