FDA 510(k) Application Details - K190454

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K190454
Device Name	Polymer Patient Examination Glove
Applicant	Hartalega Ngc Sdn. Bhd. Dataran Sd Pju 9 Bandar Sri Damansara 52200 MY Other 510(k) Applications for this Company
Contact	Kuan Kam Hon 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	02/25/2019
Decision Date	09/26/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review