Name: Predicase
Price: 199 USD

K-number	K161006
Device name	Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
Applicant	Hartalega Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Aug 4, 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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Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove

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