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FDA 510(k) Application Details - K232353
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K232353
Device Name
Polymer Patient Examination Glove
Applicant
Shanxi Hongjin Plastic Technology Co., Ltd.
Coal Bed Gas Industrial Zone, Qu'e Town
Daning County
Linfen 042300 CN
Other 510(k) Applications for this Company
Contact
Wu Zhigang
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
08/07/2023
Decision Date
08/31/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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