Name: Predicase
Price: 199 USD

K-number	K143277
Device name	Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),
Applicant	Lifestyle Safety Products (Hui Zhou) Co., Ltd.
Product code	LYZ
Device class	Class I
Decision date	Jul 29, 2015
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),

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