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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K222620
Device Name Sterilized Latex Surgical Gloves
Applicant
Suzhou Colour-Way New Material Co., Ltd.
# 20 Anmin Rd., Huangdai Town, Xiangcheng District
Suzhou,  CN 215152
Applicant Contact Yongping Xu
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/30/2022
Decision Date 03/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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