Name: Predicase
Price: 199 USD

K-number	K180645
Device name	Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
Applicant	Hartalega Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Nov 16, 2018
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)

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