FDA 510(k) Application Details - K213678

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K213678
Device Name	Polymer Patient Examination Glove
Applicant	Lienteh Technology Sdn Bhd Lot 6483, Jalan Sungai Puloh KU 5, Kawasan Perindustrian Sungai Puloh Klang 42100 MY Other 510(k) Applications for this Company
Contact	Irsyad Mazuki 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	11/22/2021
Decision Date	03/22/2022
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