FDA 510(k) Application Details - K190632

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K190632
Device Name	Surgeon'S Gloves
Applicant	Lenora Glove PVT LTD. Plot No: 15/104-1, Rottigoundanur, Thirumalayampalayam P.O. Coimbatore 641105 IN Other 510(k) Applications for this Company
Contact	Antony Kurian 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	03/12/2019
Decision Date	10/24/2019
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