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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 K022087
Device Name DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
Applicant
Shanghai PT Plastics Enterprise Company, Ltd.
268 Yushu Rd., Cangqiao
Township, Songjiang County
Shanghai,  CN 201600
Applicant Contact PETER WANG
Correspondent
Shanghai PT Plastics Enterprise Company, Ltd.
268 Yushu Rd., Cangqiao
Township, Songjiang County
Shanghai,  CN 201600
Correspondent Contact PETER WANG
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/27/2002
Decision Date 07/11/2002
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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