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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 K891322
Device Name DISPOSABLE LATEX EXAMINATION GLOVES
Applicant
Duflex Products Sdn. Bhd.
1400 S. Mountain Ave.
Suite C-D
Duarte,  CA  91010
Applicant Contact JOHN THOMPSON
Correspondent
Duflex Products Sdn. Bhd.
1400 S. Mountain Ave.
Suite C-D
Duarte,  CA  91010
Correspondent Contact JOHN THOMPSON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/13/1989
Decision Date 03/31/1989
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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