Name: Predicase
Price: 199 USD

K-number	K090327
Device name	POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE
Applicant	Wear Safe (Malaysia) Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	Apr 3, 2009
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE

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