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FDA 510(k) Application Details - K171873
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K171873
Device Name
Polymer Patient Examination Glove
Applicant
Zhonghong Pulin Medical Products Co., Ltd.
Pachigang Industrial Park, Luannan County
Tangshan 063502 CN
Other 510(k) Applications for this Company
Contact
Jinge Li
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
06/23/2017
Decision Date
11/15/2017
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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