Name: Predicase
Price: 199 USD

K-number	K010719
Device name	POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
Applicant	Perusahaan Getah Asas Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Apr 10, 2001
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 GLOVE, PURPLE COLOR

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