FDA 510(k) Application Details - K171667

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K171667
Device Name	Polymer Patient Examination Glove
Applicant	Professional Latex Sdn Bhd Lot 52, Jalan Logam 2, Kamunting Raya lndustrial Kamunting 34600 MY Other 510(k) Applications for this Company
Contact	Yoon Lim Kok 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	06/05/2017
Decision Date	09/08/2017
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