Name: Predicase
Price: 199 USD

K-number	K972306
Device name	POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE
Applicant	P.T. Irama Dinamika Latex
Product code	LZA
Device class	Class I
Decision date	Sep 12, 1997
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 NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE

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