FDA 510(k) Application Details - K051333

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K051333
Device Name	Polymer Patient Examination Glove
Applicant	SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. 238/1 RATCHADA-PISEK ROAD HUAY-KWANG, BANGKOK 10310 THAILAND TH Other 510(k) Applications for this Company
Contact	ANAN JETSADAWISUT Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2005
Decision Date	07/22/2005
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