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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K992830
Device Name SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE
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 Number880.6250
Classification Product Code
LZA  
Date Received08/23/1999
Decision Date 10/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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