Name: Predicase
Price: 199 USD

K-number	K171104
Device name	Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
Applicant	Yty Industry (Manjung) Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Aug 25, 2017
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)

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