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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 K894121
Device Name PATIENT EXAMINATION GLOVES
Applicant
PRO-TEX PRODUCTS, INC.
BALLSTON PLAZA I
1010 NORTH GLEBE RD. SUITE 890
ARLINGTON,  VA  22201
Applicant Contact ANTONIO ROMUALDEZ
Correspondent
PRO-TEX PRODUCTS, INC.
BALLSTON PLAZA I
1010 NORTH GLEBE RD. SUITE 890
ARLINGTON,  VA  22201
Correspondent Contact ANTONIO ROMUALDEZ
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/12/1989
Decision Date 01/02/1990
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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