Name: Predicase
Price: 199 USD

K-number	K003653
Device name	STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
Applicant	Wrp Asia Pacific Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	Jan 26, 2001
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)

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