FDA 510(k) Application Details - K192328

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K192328
Device Name	Surgeon'S Gloves
Applicant	JR Engineering & Medical Technologies (M) SDN.BHD. Lot 8 &10, Jalan Zurah 3 & Lot 1 & 3, Jalan Zurah 3A/1, Pusat Perindustrian 2 Hulu Selangor 44200 MY Other 510(k) Applications for this Company
Contact	Ganesan Subramaniam 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	08/27/2019
Decision Date	03/10/2020
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