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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 K893351
Device Name LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX)
Applicant
China National Medicines & Health Prod. I/E Corp.
196 Jingwu Rd., Hankou
Wuhan Hubei,  CN
Applicant Contact WEI-MIN HU
Correspondent
China National Medicines & Health Prod. I/E Corp.
196 Jingwu Rd., Hankou
Wuhan Hubei,  CN
Correspondent Contact WEI-MIN HU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/21/1989
Decision Date 11/17/1989
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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