FDA 510(k) Application Details - K213775

Device Classification Name	Latex Patient Examination Glove   More FDA Info for this Device
510(K) Number	K213775
Device Name	Latex Patient Examination Glove
Applicant	Avecena Gloves Sdn Bhd Lot 50592 Sendayan Techvalley Bandar Sri Sendayan Seremban Negeri Sembilan 71950 MY Other 510(k) Applications for this Company
Contact	Mohd Aswad bin Ramli 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	12/02/2021
Decision Date	04/24/2022
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