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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K925628
Device Name ULTRATUFF CUT RESISTANT GLOVE LINER
Applicant
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355
Applicant Contact JAN ROBERTSON
Correspondent
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355
Correspondent Contact JAN ROBERTSON
Regulation Number878.4040
Classification Product Code
LYU  
Date Received11/06/1992
Decision Date 07/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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