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FDA 510(k) Application Details - K222534
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K222534
Device Name
Polymer Patient Examination Glove
Applicant
Jiangxi Jiangxi Zhonghong Pulin Medical Products Co.,Ltd.
Yinshawan Park, High-tech Industrial Park, Hukou County
Jiujiang 332599 CN
Other 510(k) Applications for this Company
Contact
Zhou Ziyu
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
08/22/2022
Decision Date
11/23/2022
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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