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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K880480
Device Name DUNFORD SURGEON'S STERILE GLOVES
Applicant
Phillippine Radiant C/O U.S. Polymer Industries
11-38 30th Rd.
Astoria,  NY  11102
Applicant Contact ANG, MD
Correspondent
Phillippine Radiant C/O U.S. Polymer Industries
11-38 30th Rd.
Astoria,  NY  11102
Correspondent Contact ANG, MD
Regulation Number878.4460
Classification Product Code
KGO  
Date Received02/04/1988
Decision Date 06/17/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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