Name: Predicase
Price: 199 USD

K-number	K181066
Device name	Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
Applicant	Eco Medi Glove Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Sep 26, 2018
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 Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims

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