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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 K952793
Device Name SAFESKIN
Applicant
Safeskin Corp.
6815 Flanders Dr.,
Suite 150
San Diego,  CA  92121
Applicant Contact WAVA TRUSCOTT
Correspondent
Safeskin Corp.
6815 Flanders Dr.,
Suite 150
San Diego,  CA  92121
Correspondent Contact WAVA TRUSCOTT
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/19/1995
Decision Date 08/11/1995
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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