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FDA 510(k) Application Details - K212639
Device Classification Name
Patient Examination Glove, Specialty
More FDA Info for this Device
510(K) Number
K212639
Device Name
Patient Examination Glove, Specialty
Applicant
Jiangsu Nanfang Medical Co., Ltd
No. 1 Guoxiang Rd, Wujin Economic Development Zone,
Wujin
Changzhou 213149 CN
Other 510(k) Applications for this Company
Contact
Xia Li
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/20/2021
Decision Date
12/08/2021
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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