FDA 510(k) Application Details - K191898

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K191898
Device Name	Surgeon'S Gloves
Applicant	Modern Healthcare Corp. No. 751, Chung Chou Road, Sec. 2, Tien Chung County Chang-Hwa 520456 TW Other 510(k) Applications for this Company
Contact	Ke-Min Jen Other 510(k) Applications for this Contact
Regulation Number	878.4460   More FDA Info for this Regulation Number
Classification Product Code	KGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2019
Decision Date	12/18/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review