FDA 510(k) Application Details - K151997

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K151997
Device Name	Polymer Patient Examination Glove
Applicant	HARTALEGA NGC SDN BHD NO. 1, PERSIARAN TANJUNG, LOT PT4330 KAWASAN PERINDUSTRIAN TANJUNG, JALAN B20 SEPANG 64000 MY Other 510(k) Applications for this Company
Contact	Kuan Mun Leong 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	07/20/2015
Decision Date	03/31/2016
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