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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 K240790
Device Name Polyisoprene Surgical gloves
Applicant
Suzhou Colour-Way New Material Co., Ltd.
# 20, Anmin Rd., Huangdai Town, Xiangcheng District,
Suzhou City, Jiangsu Province, People'S Republic Of China
Suzhou,  CN
Applicant Contact Yingfang Qian
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/22/2024
Decision Date 08/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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