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FDA 510(k) Application Details - K142992
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K142992
Device Name
Surgeon'S Gloves
Applicant
SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD
No.36 Leizhou Road, Xinghuo Development Area
Fengxian District
Shanghai 201419 CN
Other 510(k) Applications for this Company
Contact
Xiaoyan Wang
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
10/16/2014
Decision Date
03/18/2015
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
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