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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K884882
Device Name ORIENT, LATEX SURGICAL GLOVES, STERILE
Applicant
Rosa Intl.
P.O. Box 31219
San Francisco,  CA  94131
Applicant Contact ROBERT SAHAKIAN
Correspondent
Rosa Intl.
P.O. Box 31219
San Francisco,  CA  94131
Correspondent Contact ROBERT SAHAKIAN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/22/1988
Decision Date 05/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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