FDA 510(k) Application Details - K994248

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K994248
Device Name	Vinyl Patient Examination Glove
Applicant	SHINEMOUND ENTERPRISE, INC. 17A STERLING RD. NORTH BILLERICA, MA 01862 US Other 510(k) Applications for this Company
Contact	HUAN-CHUNG LI 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	12/16/1999
Decision Date	01/28/2000
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