FDA 510(k) Application Details - K100856

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K100856
Device Name	Vinyl Patient Examination Glove
Applicant	SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD. ROOM 1606 BUILDING, 1 JIAN XIANG YUAN NO. 209 BEI BEIJING 100083 CN Other 510(k) Applications for this Company
Contact	CHU XIAOAN 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	03/26/2010
Decision Date	05/19/2010
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