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FDA 510(k) Application Details - K210106
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K210106
Device Name
Polymer Patient Examination Glove
Applicant
Zhenjiang Huayang Latex Products Co., Ltd.
Lianhe Village, Xinba Town
Yangzhong 212212 CN
Other 510(k) Applications for this Company
Contact
Han Sheng
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
01/15/2021
Decision Date
04/07/2021
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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