Name: Predicase
Price: 199 USD

K-number	K173942
Device name	Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Applicant	Central Medicare Sdn Bhd
Product code	LZC
Device class	Class I
Decision date	Mar 5, 2018
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs

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