Name: Predicase
Price: 199 USD

K-number	K893695
Device name	PATIENT EXAM GLOVES(MFG: SHANGHAI HUA LING LAT FAC
Applicant	Shanghai Industrial Investment Co. , Ltd.
Product code	LYY
Device class	Class I
Decision date	Sep 13, 1989
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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PATIENT EXAM GLOVES(MFG: SHANGHAI HUA LING LAT FAC

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