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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 K895669
Device Name POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES
Applicant
Safeskin Corp.
1701 Ponce De Leon Blvd.
Coral Gables,  FL  33134
Applicant Contact JEANNE BRAVERMAN
Correspondent
Safeskin Corp.
1701 Ponce De Leon Blvd.
Coral Gables,  FL  33134
Correspondent Contact JEANNE BRAVERMAN
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/19/1989
Decision Date 11/03/1989
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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