FDA 510(k) Application Details - K160781

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K160781
Device Name	Surgeon'S Gloves
Applicant	SEMPERIT INVESTMENTS ASIA PTE. LTD. 8 Jurong Town Hall Road #29 - 03 To 06 Jtc Summit SINGAPORE 609434 SG Other 510(k) Applications for this Company
Contact	CLEMENS EICHLER 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	03/22/2016
Decision Date	05/02/2017
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