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510(k) Premarket Notification Database

Device Classification Name:	GLOVE, PATIENT EXAMINATION, VINYL
Regulation Number:	880.6250 [See Other Products with this regulation number]
510(k) Number:	K031108
Device Name:	SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
Applicant:	SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT 590 W. CENTRAL AVE # D BREA, CA 92821
Contact:	JAMES CHU
Product Code:	LYZ [See Other Manufacturers that make this Product]
Date Received:	04-22-2003
Decision Date:	09-08-2003
Decision:	SE
Advisory Committee:	HO
Statement/Summary/Purged Status:	Summary
Type:	Traditional
Review by Third Party:	N
Expedited Review:	N

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