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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 K982015
Device Name VINYL PATIENT EXAMINATION POWDER FREE GLOVES, NON-STERILE
Applicant
Taian Plastics Products (Jingxing) Co., Ltd.
The N. Of Beishimen Village
Xiao Zuo Town, Jingxing County
Shijiazhuang City, Hebei Prov.,  CN 050306
Applicant Contact MR.LIN CHIN-YU
Correspondent
Taian Plastics Products (Jingxing) Co., Ltd.
The N. Of Beishimen Village
Xiao Zuo Town, Jingxing County
Shijiazhuang City, Hebei Prov.,  CN 050306
Correspondent Contact MR.LIN CHIN-YU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/08/1998
Decision Date 08/03/1998
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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