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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 K893450
Device Name LATEX EXAMINATION GLOVES
Applicant
Ken FA Latex Products Corp.
Nan Shan, 11 Renmin S.
Rd.
Zhanjiang, Guangdong,  CN
Applicant Contact YUAN RI-XIN
Correspondent
Ken FA Latex Products Corp.
Nan Shan, 11 Renmin S.
Rd.
Zhanjiang, Guangdong,  CN
Correspondent Contact YUAN RI-XIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/03/1989
Decision Date 08/31/1989
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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