FDA 510(k) Application Details - K974777

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K974777
Device Name	Vinyl Patient Examination Glove
Applicant	SUN FLOWER GLOVES CO., LTD. 3423 INVESTMENT BLVD. SUITE 12 HAYWARD, CA 94545 US Other 510(k) Applications for this Company
Contact	DAVID HU Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/1997
Decision Date	01/30/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review