FDA 510(k) Application Details - K183562

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K183562
Device Name	Patient Examination Glove, Specialty
Applicant	Encompass Industries Sdn. Bhd. Lot 18256, Kawasan Perindustrian Lot Q Kertih Bio-Polymer Park Kemaman 24300 MY Other 510(k) Applications for this Company
Contact	Eunice Yee Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2018
Decision Date	10/23/2019
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