FDA 510(k) Application Details - K212802

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K212802
Device Name	Polymer Patient Examination Glove
Applicant	Hong Seng Gloves Sdn Bhd LOT 97, Jalan 10, Kawasan Perusahaan Bakar Arang Sungai Petani 08000 MY Other 510(k) Applications for this Company
Contact	Ho Chia Yao 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	09/02/2021
Decision Date	12/02/2021
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