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FDA 510(k) Application Details - K182115
Device Classification Name
Vinyl Patient Examination Glove
More FDA Info for this Device
510(K) Number
K182115
Device Name
Vinyl Patient Examination Glove
Applicant
Ping An Medical Products Co., Ltd.
Zhe Ji road, High-tech Industrial Zone of
Hukou County
Jiu Jiang 332000 CN
Other 510(k) Applications for this Company
Contact
Fu Dong Zhang
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/06/2018
Decision Date
10/03/2018
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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