Name: Predicase
Price: 199 USD

K-number	K001485
Device name	HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
Applicant	Pwa Industries Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	Jun 13, 2000
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES

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