FDA 510(k) Application Details - K152479

Device Classification Name	Polymer Patient Examination Glove   More FDA Info for this Device
510(K) Number	K152479
Device Name	Polymer Patient Examination Glove
Applicant	HEALTHY GLOVE CO.,LTD 119 Kanchanavanich Road, Tambol Patong Hat Yai 90230 TH Other 510(k) Applications for this Company
Contact	TEOH CHOH SHEE 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	08/31/2015
Decision Date	04/04/2016
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