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FDA 510(k) Application Details - K213048
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K213048
Device Name
Polymer Patient Examination Glove
Applicant
Huayuan Medical Technology(Shangqiu) Co., Ltd.
In The North Yard of West 1000m Road At
The Intersection of Zhuangzhou Avenue and Pingyuan R
Shangqiu 476000 CN
Other 510(k) Applications for this Company
Contact
Huamei Wang
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
09/22/2021
Decision Date
12/18/2021
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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