Name: Predicase
Price: 199 USD

K-number	K100978
Device name	POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE
Applicant	Jiangsu Sunshine Plastic Products, Co., Ltd.
Product code	LYZ
Device class	Class I
Decision date	Aug 12, 2010
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 NON-STERILE VINYL EXAMINATION GLOVE

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