K-number	K121526
Device name	POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
Applicant	Shandong Junchi Medical Products Co., Ltd.
Product code	LZA
Device class	Class I
Decision date	Aug 3, 2012
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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POWER-FREE NITRILE PATIENT EXAMINATION GLOVES

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