FDA 510(k) Application Details - K202401

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K202401
Device Name	Surgeon'S Gloves
Applicant	ECO Medi Glove Sdn. Bhd Lot 26910, Lorong Perusahaan 3/3, Kawasan Perusahaan, Kamunting Raya Taiping 34600 MY Other 510(k) Applications for this Company
Contact	Suresh Kumar Other 510(k) Applications for this Contact
Regulation Number	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2020
Decision Date	02/17/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review