Name: Predicase
Price: 199 USD

K-number	K142805
Device name	Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)
Applicant	Hartalega Sdb. Bhd.
Product code	LZA
Device class	Class I
Decision date	Dec 18, 2014
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU)

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