Name: Predicase
Price: 199 USD

K-number	K082302
Device name	POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
Applicant	Pt. Medisafe Technologies
Product code	LZA
Device class	Class I
Decision date	Dec 9, 2008
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 NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM

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