FDA 510(k) Application Details - K212848

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K212848
Device Name	Surgeon'S Gloves
Applicant	Pentavest Holdings Sdn Bhd No. 9574-9578, Jalan PTB 2 , Kawasan Perindustrian Tangga, Batu 76400 MY Other 510(k) Applications for this Company
Contact	Teng Boon Joo Other 510(k) Applications for this Contact
Regulation Number	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2021
Decision Date	12/27/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review