FDA 510(k) Application Details - K042645

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K042645
Device Name	Latex Patient Examination Glove
Applicant	QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD 2576 LAFAYETTE ST. SANTA CLARA, CA 95050 US Other 510(k) Applications for this Company
Contact	ZECHUAN SHAO 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	09/27/2004
Decision Date	11/26/2004
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