Name: Predicase
Price: 199 USD

K-number	K021659
Device name	PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)
Applicant	P.T. Healthcare Glovindo
Product code	LYY
Device class	Class I
Decision date	Aug 12, 2002
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)

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