Name: Predicase
Price: 199 USD

K-number	K022343
Device name	GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)
Applicant	Pt. Wrp Buana Multicorpora
Product code	LYY
Device class	Class I
Decision date	Sep 16, 2002
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)

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