Name: Predicase
Price: 199 USD

K-number	K093375
Device name	KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)
Applicant	Koon Seng Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Dec 2, 2009
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)

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