Name: Predicase
Price: 199 USD

K-number	K050526
Device name	POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR
Applicant	Spi Gloves Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	Dec 6, 2005
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR

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