FDA 510(k) Application Details - K003197

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K003197
Device Name	Vinyl Patient Examination Glove
Applicant	KAOHSIUNG BROTHERS PRODUCTS CORP. 23 KOOSHAN 3RD RD. KAOHSIUNG 80414 TW Other 510(k) Applications for this Company
Contact	STONE CHEN 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	10/12/2000
Decision Date	11/22/2000
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