FDA 510(k) Application Details - K973998

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K973998
Device Name	Vinyl Patient Examination Glove
Applicant	EVERRISE GLOVE PRODUCTS CO., LTD. # 47 HUAN KUNG RD, WANG HAUN LI, YUNG KANG CITY TAINAN HSIEN 710 TW Other 510(k) Applications for this Company
Contact	JASON CHANG 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	10/21/1997
Decision Date	11/18/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review