Name: Predicase
Price: 199 USD

K-number	K052892
Device name	SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55
Applicant	Barriermed Glove Co.
Product code	LZA
Device class	Class I
Decision date	Nov 30, 2005
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55

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