Name: Predicase
Price: 199 USD

K-number	K993918
Device name	HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION
Applicant	Pamitex Industries Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Feb 10, 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 MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION

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