FDA 510(k) Application Details - K221648

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K221648
Device Name	Latex Patient Examination Glove
Applicant	Iconic medicare sdn bhd PMT 798, Lingkaran Cassia Selatan, Taman Perindustrian, Bandar Cassia Batu Kawan 14110 MY Other 510(k) Applications for this Company
Contact	Tan Cho Chia Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2022
Decision Date	08/25/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review