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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 K895448
Device Name RUBBER LATEX SURGICAL GLOVES, STERILE
Applicant
Dah Lee Rubber Industries (Thai) , Ltd.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
Dah Lee Rubber Industries (Thai) , Ltd.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number878.4460
Classification Product Code
KGO  
Date Received09/08/1989
Decision Date 10/10/1989
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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