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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K011792
Device Name NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
Applicant
Latexx Partners Bhd.
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact CHRISTINA SMITH
Correspondent
Latexx Partners Bhd.
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact CHRISTINA SMITH
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/08/2001
Decision Date 08/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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