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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 K121925
Device Name POWDERED LATEX SURGEON'S GLOVE
Applicant
Suzhou Colour-Way Enterprise Development Co., Ltd.
83 Changping Rd., Dongqiao
Industrial Area
Suzhou, Jiangsu,  CN 215152
Applicant Contact ZHU YINGQIU
Correspondent
Suzhou Colour-Way Enterprise Development Co., Ltd.
83 Changping Rd., Dongqiao
Industrial Area
Suzhou, Jiangsu,  CN 215152
Correspondent Contact ZHU YINGQIU
Regulation Number878.4460
Classification Product Code
KGO  
Date Received07/02/2012
Decision Date 08/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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