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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 K002720
Device Name FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO
Applicant
Tillotson Healthcare Corp.
360 Route 101
Bedford,  NH  03110 -5030
Applicant Contact F.W. PERRELLA
Correspondent
Tillotson Healthcare Corp.
360 Route 101
Bedford,  NH  03110 -5030
Correspondent Contact F.W. PERRELLA
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/31/2000
Decision Date 11/09/2000
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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