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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 K892026
Device Name PROLAX PATIENT EXAMINATION GLOVES (LATEX)
Applicant
ERGO INTL., ENT., INC.
2291 N.E.164 ST. BAY #
2291
NORTH MIAMI BEACH,  FL  33160
Applicant Contact BERTHA ERTEL
Correspondent
ERGO INTL., ENT., INC.
2291 N.E.164 ST. BAY #
2291
NORTH MIAMI BEACH,  FL  33160
Correspondent Contact BERTHA ERTEL
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/30/1989
Decision Date 05/25/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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