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FDA 510(k) Application Details - K240072
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K240072
Device Name
Polymer Patient Examination Glove
Applicant
Luliang Hongruida Health Protection Technology Co., Ltd.
Zhaokua Area, Luliang Industrial Zone,
Qujing 655606 CN
Other 510(k) Applications for this Company
Contact
Guocai Zhang
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
01/10/2024
Decision Date
02/09/2024
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
FDA Source Information for K240072
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