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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 K991317
Device Name POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Applicant
Safeskin Corp.
12671 High Bluff Dr.
San Diego,  CA  92130
Applicant Contact EUGENE V GOORCHENKO
Correspondent
Safeskin Corp.
12671 High Bluff Dr.
San Diego,  CA  92130
Correspondent Contact EUGENE V GOORCHENKO
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/19/1999
Decision Date 05/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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