Name: Predicase
Price: 199 USD

K-number	K001327
Device name	POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)
Applicant	Premier Pathway Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	May 23, 2000
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 EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)

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