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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 K002814
Device Name DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
Applicant
Shanghai PM Plastics Enterise Co., Ltd.
258 Yushu Rd.
Cangqiao Township
Shongjiang County, Shanghai,  CN
Applicant Contact CHANG T SUN
Correspondent
Shanghai PM Plastics Enterise Co., Ltd.
258 Yushu Rd.
Cangqiao Township
Shongjiang County, Shanghai,  CN
Correspondent Contact CHANG T SUN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/11/2000
Decision Date 10/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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