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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K954573
Device Name PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES
Applicant
Tillotson Healthcare Corp.
360 Rte. 101
Bedford,  NH  03110
Applicant Contact IMOGENE TIBBETTS
Correspondent
Tillotson Healthcare Corp.
360 Rte. 101
Bedford,  NH  03110
Correspondent Contact IMOGENE TIBBETTS
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/02/1995
Decision Date 12/21/1995
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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