Name: Predicase
Price: 199 USD

K-number	K082125
Device name	N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT
Applicant	Best Glove, Inc.
Product code	LZA
Device class	Class I
Decision date	Nov 21, 2008
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT

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