Name: Predicase
Price: 199 USD

K-number	K032010
Device name	GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
Applicant	Pt. Wrp Buana Multicorpora
Product code	LZA
Device class	Class I
Decision date	Aug 19, 2003
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE

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