FDA 510(k) Application Details - K203483

Device Classification Name	Surgeon'S Gloves   More FDA Info for this Device
510(K) Number	K203483
Device Name	Surgeon'S Gloves
Applicant	Guilin HBM Health Protections, Inc. No.1-2, Shuijing East Road, Economic and Technological Development Area Guilin 541805 CN Other 510(k) Applications for this Company
Contact	Pu Lei 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	11/27/2020
Decision Date	02/01/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review