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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 K901750
Device Name LATEX PATIENT EXAMINATION GLOVES
Applicant
Haikou Latex Factory
Wenming Dong Rd.
Hainan Island
Haikou City,  CN
Applicant Contact ZENG HUIQIN
Correspondent
Haikou Latex Factory
Wenming Dong Rd.
Hainan Island
Haikou City,  CN
Correspondent Contact ZENG HUIQIN
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/17/1990
Decision Date 05/02/1990
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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