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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 K882431
Device Name CONFIDENCE(TM) STERILE, DISP., LATEX SURG. GLOVES
Applicant
Charise Charles, Ltd.
2400 Maitland Center Pkwy.,
#120
Maitland,  FL  32751
Applicant Contact MARTIN A NASSIF
Correspondent
Charise Charles, Ltd.
2400 Maitland Center Pkwy.,
#120
Maitland,  FL  32751
Correspondent Contact MARTIN A NASSIF
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/14/1988
Decision Date 12/02/1988
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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