Name: Predicase
Price: 199 USD

K-number	K163017
Device name	Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
Applicant	Gmp Medicare Sdn. Bhd.
Product code	LZC
Device class	Class I
Decision date	Mar 22, 2017
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

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