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FDA 510(k) Application Details - K212998
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K212998
Device Name
Polymer Patient Examination Glove
Applicant
Alcatron Gloves Factory
NO. 12-1, Xing' an Road East, Linqu
Weifang 262600 CN
Other 510(k) Applications for this Company
Contact
Hui Zhao
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
09/20/2021
Decision Date
02/19/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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