Name: Predicase
Price: 199 USD

K-number	K013443
Device name	POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2
Applicant	Maxter Glove Manufacturing Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Nov 29, 2001
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2

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