FDA 510(k) Application Details - K212408

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K212408
Device Name	Polymer Patient Examination Glove
Applicant	Pt. Maja Agung Latexindo Jl. Utama No. 98, Pujimulyo Sunggal, Deli Serdang 20352 ID Other 510(k) Applications for this Company
Contact	Sivaprakash S 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	08/03/2021
Decision Date	05/18/2022
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