FDA 510(k) Application Details - K230777

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K230777
Device Name	Polymer Patient Examination Glove
Applicant	3A Glove Sdn. Bhd. PTD 2058 & 2059, Jalan Cyber 4, Kawasan Perindustrian Senai (III) Senai 81400 MY Other 510(k) Applications for this Company
Contact	Kumar Durarajen 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	03/21/2023
Decision Date	10/06/2023
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