Name: Predicase
Price: 199 USD

K-number	K001280
Device name	COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
Applicant	Wrp Asia Pacific Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	May 15, 2000
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES

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