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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K902278
Device Name PVC PATIENT EXAMINATION GLOVE
Applicant
Fujian Province Jiu Zhou Group
2354 NE 94th
Seattle,  WA  98115
Applicant Contact LISA ZHANG
Correspondent
Fujian Province Jiu Zhou Group
2354 NE 94th
Seattle,  WA  98115
Correspondent Contact LISA ZHANG
Regulation Number880.6250
Classification Product Code
FMC  
Date Received05/22/1990
Decision Date 08/29/1990
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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