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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 K893366
Device Name LATEX EXAMINATION GLOVES
Applicant
Jinshan Caojing Latex Factory
1250 Broadway
18th Floor
New York,  NY  10001
Applicant Contact LEUNG
Correspondent
Jinshan Caojing Latex Factory
1250 Broadway
18th Floor
New York,  NY  10001
Correspondent Contact LEUNG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/25/1989
Decision Date 11/27/1989
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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