Name: Predicase
Price: 199 USD

K-number	K962188
Device name	COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
Applicant	Wembley Rubber Products (M) Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Jul 26, 1996
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)

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