FDA 510(k) Application Details - K142685

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K142685
Device Name	Polymer Patient Examination Glove
Applicant	SIAM SEMPERMED CORP., LTD 10 SOI 10 PHETKASEM RD. HATYAI 90110 TH Other 510(k) Applications for this Company
Contact	ANAN PRUKSANUSAK 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	09/22/2014
Decision Date	02/11/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review