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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 K001432
Device Name DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE
Applicant
SHANGHAI PM PLASTICS ENT. CO., LTD.
NO. 258, YUSHU RD. CHANGQIAO
TOWNSHIP, SHOHJIANG COUNTY, SH,  CN
Applicant Contact CHANG T SUN
Correspondent
SHANGHAI PM PLASTICS ENT. CO., LTD.
NO. 258, YUSHU RD. CHANGQIAO
TOWNSHIP, SHOHJIANG COUNTY, SH,  CN
Correspondent Contact CHANG T SUN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received05/08/2000
Decision Date 07/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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