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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 K000223
Device Name NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
Applicant
Phoenix Medical Technology, Inc.
Hwy. 521 W., P.O. Box 346
Andrews,  SC  29510
Applicant Contact GROVER C MIXON
Correspondent
Phoenix Medical Technology, Inc.
Hwy. 521 W., P.O. Box 346
Andrews,  SC  29510
Correspondent Contact GROVER C MIXON
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/24/2000
Decision Date 04/14/2000
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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