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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 K024026
Device Name DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
Applicant
Shanghai PM Plastics Enterise Co., Ltd.
258 Yushu Rd.
Cangqiao Township
Shongjiang County, Shanghai,  CN 201600
Applicant Contact CHANG TE SUN
Correspondent
Shanghai PM Plastics Enterise Co., Ltd.
258 Yushu Rd.
Cangqiao Township
Shongjiang County, Shanghai,  CN 201600
Correspondent Contact CHANG TE SUN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received12/06/2002
Decision Date 12/18/2002
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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