FDA 510(k) Application Details - K171171

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K171171
Device Name	Polymer Patient Examination Glove
Applicant	Koon Seng Sdn. Bhd. PTD 16058 Kawasan Perindustrian Tangkak Jalan Muar 84900 MY Other 510(k) Applications for this Company
Contact	Koon Seng Sdn. Bhd. 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	04/21/2017
Decision Date	02/22/2018
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