Name: Predicase
Price: 199 USD

K-number	K121591
Device name	FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
Applicant	Tekmedic (M) Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Oct 11, 2012
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)

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