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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 K891934
Device Name ADDWEALTH LATEX EXAMINATION GLOVES
Applicant
PRECISION TRADING INTL., INC.
4753 DISTRIBUTION DR.
TAMPA,  FL  33605
Applicant Contact PENN TALIAFERRO
Correspondent
PRECISION TRADING INTL., INC.
4753 DISTRIBUTION DR.
TAMPA,  FL  33605
Correspondent Contact PENN TALIAFERRO
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/28/1989
Decision Date 05/12/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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