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FDA 510(k) Application Details - K230542
Device Classification Name
Polymer Patient Examination Glove
More FDA Info for this Device
510(K) Number
K230542
Device Name
Polymer Patient Examination Glove
Applicant
Huizhou Anboson Technology Co., Ltd.
2F, No.7, Hechang East Fourth Road, Zhongkai High-tech Zone
Huizhou 516001 CN
Other 510(k) Applications for this Company
Contact
Xuanli Weng
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
02/28/2023
Decision Date
05/31/2023
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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