FDA 510(k) Application Details - K964817

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K964817
Device Name	Latex Patient Examination Glove
Applicant	DERLIN COMPANY LTD. 4TH FLR., NO. 15, ALLEY 7, LANE 130 SEC. 3, MING SHENG E. RD. TAIPEI ROC TW Other 510(k) Applications for this Company
Contact	EDDY D LIOU Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/1996
Decision Date	01/24/1997
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