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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 K002719
Device Name FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A
Applicant
Tillotson Healthcare Corp.
360 Rte. 101
Bedford,  NH  03110
Applicant Contact F.W. PERRELLA
Correspondent
Tillotson Healthcare Corp.
360 Rte. 101
Bedford,  NH  03110
Correspondent Contact F.W. PERRELLA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/31/2000
Decision Date 01/26/2001
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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