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FDA 510(k) Application Details - K212834
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K212834
Device Name
Polymer Patient Examination Glove
Applicant
Siyang Threeguard Medical Supplies Co.,Ltd.
East of Nanhai Road and South of Guilin Road,
Economic Development Zone, Siyang County
Suqian 223799 CN
Other 510(k) Applications for this Company
Contact
Guo Hua
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
09/07/2021
Decision Date
12/30/2021
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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