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FDA 510(k) Application Details - K222620
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K222620
Device Name
Surgeon'S Gloves
Applicant
Suzhou Colour-way New Material Co., Ltd.
No. 20, Anmin Road, Huangdai Town,
Xiangcheng District
Suzhou 215152 CN
Other 510(k) Applications for this Company
Contact
Yongping Xu
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/30/2022
Decision Date
03/23/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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