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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 K010961
Device Name X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Applicant
Ansell Healthcare Products, Inc.
1875 Harsh Ave. SE
Massillon,  OH  44646
Applicant Contact JAMES R CHATTERTON
Correspondent
Ansell Healthcare Products, Inc.
1875 Harsh Ave. SE
Massillon,  OH  44646
Correspondent Contact JAMES R CHATTERTON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/30/2001
Decision Date 05/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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