Name: Predicase
Price: 199 USD

K-number	K110979
Device name	DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS
Applicant	Advanced Medical Products Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Oct 20, 2011
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS

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