FDA 510(k) Application Details - K183441

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K183441
Device Name	Polymer Patient Examination Glove
Applicant	Semperit Investments Asia PTE LTD. 8 Jurong Town Hall Road, #29-03 To 06 The JTC Summit Singapore 609434 SG Other 510(k) Applications for this Company
Contact	Andreas Woess 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	12/12/2018
Decision Date	10/04/2019
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