Name: Predicase
Price: 199 USD

K-number	K162175
Device name	Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less
Applicant	Vietglove Corporation
Product code	LYY
Device class	Class I
Decision date	Nov 21, 2016
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less

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