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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K052985
Device Name POWDER FREE VINYL EXAMINATION GLOVE
Applicant
Tg Medical (China) Incorporation
3 Xitang Rd.
Xizhang Town
Zhangjiagang, Jiangsu Province,  CN 215614
Applicant Contact WU KIN YEAP
Correspondent
Tg Medical (China) Incorporation
3 Xitang Rd.
Xizhang Town
Zhangjiagang, Jiangsu Province,  CN 215614
Correspondent Contact WU KIN YEAP
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/24/2005
Decision Date 01/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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