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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 K891884
Device Name PATIENT EXAMINATION GLOVES (LATEX)
Applicant
Duflex Products Sdn. Bhd.
Lot. 2, Persiaran Sultan
Shah Alam Industrial Estate
40000 Shah Alam, Selangor,  MY
Applicant Contact J. G THOMPSON
Correspondent
Duflex Products Sdn. Bhd.
Lot. 2, Persiaran Sultan
Shah Alam Industrial Estate
40000 Shah Alam, Selangor,  MY
Correspondent Contact J. G THOMPSON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/28/1989
Decision Date 04/13/1989
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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