FDA 510(k) Application Details - K203074

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K203074
Device Name	Latex Patient Examination Glove
Applicant	PT. Universal Gloves Jl. Pertahanan No. 17 Patumbak Medan 20361 ID Other 510(k) Applications for this Company
Contact	Li I-Feng Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2020
Decision Date	11/19/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review