FDA 510(k) Application Details - K232764

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K232764
Device Name	Polymer Patient Examination Glove
Applicant	ECO Medi Glove Sdn. Bhd Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate Taiping 34600 MY Other 510(k) Applications for this Company
Contact	Suresh Kumar 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	09/08/2023
Decision Date	02/07/2024
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