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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Examination Glove
510(k) Number K932404
Device Name NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
Applicant
Safeskin Corp.
Crocker Center
5100 Town Center Cir.
Boca Raton,  FL  33486
Applicant Contact JEANNE D BRAVERMAN
Correspondent
Safeskin Corp.
Crocker Center
5100 Town Center Cir.
Boca Raton,  FL  33486
Correspondent Contact JEANNE D BRAVERMAN
Regulation Number880.6250
Classification Product Code
FMC  
Date Received05/13/1993
Decision Date 05/18/1994
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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