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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 K931491
Device Name SIME HEALTH SIME HYPOALLERGENIC
Applicant
Sime Health, Ltd.
1200 Sixth Ave. S.
Seattle,  WA  98134
Applicant Contact HELEN MARIESKIND
Correspondent
Sime Health, Ltd.
1200 Sixth Ave. S.
Seattle,  WA  98134
Correspondent Contact HELEN MARIESKIND
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/25/1993
Decision Date 10/15/1993
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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