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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 K001375
Device Name ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
Applicant
Best Manufacturing Company
579 Edison St.
Menlo,  GA  30731
Applicant Contact DAVID C YOUNG
Correspondent
Best Manufacturing Company
579 Edison St.
Menlo,  GA  30731
Correspondent Contact DAVID C YOUNG
Regulation Number880.6250
Classification Product Code
LZA  
Date Received05/01/2000
Decision Date 07/25/2000
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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