FDA 510(k) Application Details - K210755

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K210755
Device Name	Polymer Patient Examination Glove
Applicant	Meditech Gloves SDN BHD PT 3345, Jalan Permata 1/3, Arab Malaysian Industrial Park Nilai 71800 MY Other 510(k) Applications for this Company
Contact	Effendi Tenang 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	03/15/2021
Decision Date	05/07/2021
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