Name: Predicase
Price: 199 USD

K-number	K070519
Device name	PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES
Applicant	Zhang Jia Gang Huayuan Plastic Co. , Ltd.
Product code	LYZ
Device class	Class I
Decision date	Apr 10, 2007
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES

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