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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 K962139
Device Name SAFESKIN
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
LZA  
Date Received06/03/1996
Decision Date 12/19/1996
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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