FDA 510(k) Application Details - K232319

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K232319
Device Name	Polymer Patient Examination Glove
Applicant	UG Global Resources Sdn. Bhd. Lot 62 & 63, Lorong Senawang 3/2, Kawasan Perindustrian Senawang, Seremban 70450 MY Other 510(k) Applications for this Company
Contact	Lee Mei Ling 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	08/03/2023
Decision Date	04/22/2024
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