Name: Predicase
Price: 199 USD

K-number	K152222
Device name	NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs
Applicant	Gmp Medicare Sdn Bhd (F25)
Product code	LZC
Device class	Class I
Decision date	Apr 21, 2016
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 tested for use with Chemotheraphy Drugs

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