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FDA 510(k) Application Details - K171615
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K171615
Device Name
Polymer Patient Examination Glove
Applicant
Shandong Xingyu Gloves Co., Ltd
No.2158,Yaoqian Road,Economic Development Zone
Gaomi 261502 CN
Other 510(k) Applications for this Company
Contact
Xu Qiang
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
06/01/2017
Decision Date
07/31/2017
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
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