FDA 510(k) Application Details - K182382

Device Classification Name	Patient Examination Glove, Specialty   More FDA Info for this Device
510(K) Number	K182382
Device Name	Patient Examination Glove, Specialty
Applicant	GMP Medicare SDN BHD (F25) Lot/PT64593, JLN Dahlia/KU8, Kaw Perindustrian Meru Timur Klang 41050 MY Other 510(k) Applications for this Company
Contact	Noraini bt Raus 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	08/31/2018
Decision Date	08/29/2019
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