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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 K893143
Device Name LATEX EXAM GLOVES (MFG. GUANGDONG ZHONGSHAN)
Applicant
Guangzhou Chemicals Import & Export Corp.
255 Dong Feng Rd. W.
Ganczhou,  CN
Applicant Contact QI NING
Correspondent
Guangzhou Chemicals Import & Export Corp.
255 Dong Feng Rd. W.
Ganczhou,  CN
Correspondent Contact QI NING
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/14/1989
Decision Date 07/31/1989
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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