K-number	K990499
Device name	PREPOWDERED NITRILE EXAMINATION GLOVES
Applicant	Flexitech Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Apr 2, 1999
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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PREPOWDERED NITRILE EXAMINATION GLOVES

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