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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 K895023
Device Name LATEX PATIENT EXAMINATION GLOVE
Applicant
Beijing Latex Factory
22 King St.
Wilmington,  MA  01887
Applicant Contact WEI T SHA
Correspondent
Beijing Latex Factory
22 King St.
Wilmington,  MA  01887
Correspondent Contact WEI T SHA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/20/1989
Decision Date 11/16/1989
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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