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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K903987
Device Name TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED
Applicant
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355
Applicant Contact STEPHEN A CAMPBELL
Correspondent
Baxter Healthcare Corp
27200 N. Tourney Rd.
P.O. Box 5900
Valencia,  CA  91355
Correspondent Contact STEPHEN A CAMPBELL
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/23/1990
Decision Date 10/11/1990
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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