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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K893280
Device Name PROFECT EXAMINATION GLOVES
Applicant
Shanghai Latex Factory
5959 Westheimer Suite #366
Houston,  TX  77057
Applicant Contact DERICK LI
Correspondent
Shanghai Latex Factory
5959 Westheimer Suite #366
Houston,  TX  77057
Correspondent Contact DERICK LI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/17/1989
Decision Date 09/11/1989
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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