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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K970899
Device Name SAFESKIN POWDERED EXAMINATION GLOVE
Applicant
Safeskin Corp.
12671 High Bluff Dr.
San Diego,  CA  92130
Applicant Contact MICHELLE MOLLOY
Correspondent
Safeskin Corp.
12671 High Bluff Dr.
San Diego,  CA  92130
Correspondent Contact MICHELLE MOLLOY
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/11/1997
Decision Date 05/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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