Name: Predicase
Price: 199 USD

K-number	K993097
Device name	HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAM
Applicant	Pamitex Industries Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Oct 27, 1999
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAM

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