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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K894739
Device Name SURE-TEC LATEX EXAMINATION GLOVES
Applicant
All American Poly of Pennsylvania Corp.
111-115 Washington Ave.
Vandergrift,  PA  15690
Applicant Contact JOEY HATZFELD
Correspondent
All American Poly of Pennsylvania Corp.
111-115 Washington Ave.
Vandergrift,  PA  15690
Correspondent Contact JOEY HATZFELD
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/27/1989
Decision Date 09/26/1989
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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