Name: Predicase
Price: 199 USD

K-number	K972838
Device name	POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED)
Applicant	Absolute Synthetic Technologies Malaysia Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Aug 15, 1997
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED)

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