Name: Predicase
Price: 199 USD

K-number	K994281
Device name	BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE)
Applicant	Biopro (M) Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Oct 20, 2000
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE)

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