K-number	K974907
Device name	NITRILE PRE-POWDERED EXAMINATION GLOVES
Applicant	Smart Glove Corp. Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Mar 13, 1998
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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NITRILE PRE-POWDERED EXAMINATION GLOVES

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