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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 K892577
Device Name SUNNYTEX LATEX EXAMINATION GLOVES
Applicant
Glen Nevis Co.
609 Stonegate Dr.
South San Francisco,  CA  94080
Applicant Contact HELEN SOEGANDHI
Correspondent
Glen Nevis Co.
609 Stonegate Dr.
South San Francisco,  CA  94080
Correspondent Contact HELEN SOEGANDHI
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/1989
Decision Date 05/31/1989
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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