Name: Predicase
Price: 199 USD

K-number	K981064
Device name	POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
Applicant	P.T. Irama Dinamika Latex
Product code	LZA
Device class	Class I
Decision date	Nov 5, 1998
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES

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