Name: Predicase
Price: 199 USD

K-number	K010628
Device name	POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
Applicant	Shijiazhuang Junfei Plastic Products Co., Ltd.
Product code	LYZ
Device class	Class I
Decision date	Apr 23, 2001
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES

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