Name: Predicase
Price: 199 USD

K-number	K992523
Device name	HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W
Applicant	Pamitex Industries Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Oct 18, 1999
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 PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W

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