K-number	K153732
Device name	Powder Free Blue Nitrile Examination Glove
Applicant	Qube Medical Product Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Jul 29, 2016
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 Blue Nitrile Examination Glove

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