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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K893334
Device Name PREPOWDERED VINYL EXAM GLOVES
Applicant
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Applicant Contact MARVIN D SCHATTNER
Correspondent
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Correspondent Contact MARVIN D SCHATTNER
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received04/20/1989
Decision Date 08/15/1989
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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